WormGuy
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FDA approves Amjevita, a biosimilar to Humira
For Immediate Release
September 23, 2016
Release
The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
Amjevita is approved for the following indications in adult patients:
moderately to severely active rheumatoid arthritis;
active psoriatic arthritis;
active ankylosing spondylitis (an arthritis that affects the spine);
moderately to severely active Crohn’s disease;
moderately to severely active ulcerative colitis; and
moderate to severe plaque psoriasis.
Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA’s approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. It has been approved as a biosimilar, not as an interchangeable product.
The most serious known side effects with Amjevita are infections and malignancies. The most common expected adverse reactions with Amjevita are infections and injection site reactions.
Like Humira, the labeling for Amjevita contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
Amjevita is manufactured by Amgen, Inc., of Thousand Oaks, California. Humira was approved in December 2002 and is manufactured by AbbVie Inc. of North Chicago, Illinois.
John
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Over two hours Mt_Rider. I had to make it in two post because something would not let me do it all in one.
John
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*SNIP
Major data breach alert! This could very well be the largest data breach in history so far.
If you have a Yahoo account or use any of the company's other sites such as Tumblr and Flickr, take a moment to review your accounts and change your password immediately. I also recommend you take other important security steps that I outline below.
Yahoo finally confirmed today that at least 500 million Yahoo accounts have been compromised in a 2014 attack, bigger than previously reported. I know what you're thinking, "Wow 2014, that was two years ago!" Yes, it was a few years ago and the hackers have more than your password.
Yahoo is claiming that a "state-sponsored actor" is behind the attack, which means a foreign government could be responsible for the data breach. This hack may also have serious implications on the Verizon-Yahoo merger deal that was announced earlier this year.
Information stolen may include names, email addresses, telephone numbers, birthdays, hashed passwords and even encrypted or unencrypted security questions and answers.
Here's what you need to do:
1. Change your Yahoo password now
2. Change your Yahoo secret questions and answers
3. Enable Two-step Verification
4. Set up a Yahoo Account Key
5. Check your other accounts
This is also a good time to review your banking accounts and check for signs of identity theft and fraud.
Furthermore, beware of any phishing attempts that may capitalize on the situation. Carefully scrutinize any emails, texts or calls claiming to be from Yahoo, they might be just fraudulent attempts to steal more of your personal information.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Krishna Food Corp. Recalls Bikaju Chowpati Bhelpuri Because of Possible Health Risk
For Immediate Release
September 22, 2016
Contact
Consumers
Krishna Food Corp
1-917-478-3225
Announcement
View Product Photos
Krishna Food Corp of Neshanic Station, New Jersey is recalling 16 cartons of BIKAJI Chowpati BHELPURI, NET WT: 300g 10.58 OZ Batch no 2016 F97 Best Before June 2017, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product was distributed in New York, New Jersey and Pennsylvania states, through retail stores.
The product is packed within a pouch pack.
No illnesses have been reported to date.
Recent tests conducted by the U.S. Food and Drug Administration show this product to be contaminated with Salmonella.
Consumers who have purchased the product are urged to destroy it. Consumers with questions may contact the company at 1-917-478-3225 Monday – Friday, 9:30 am – 6:00 pm, ET.
John
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METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
07272016@16
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
07272016@68
Human
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE
07272016@7
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
07272016@8
Human
SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT
07272016@83
Human
TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE
07282016@1
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
07282016@12
Human
METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE
07282016@26
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
07282016@5
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL
07282016@51
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
07292016@12
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
07292016@2
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
07292016@8
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
08012016@25
Human
ALPROSTADIL 20MCG/ML INJECTABLE
08012016@32
Human
VITAMIN D3 IN SESAME OIL 50,000 IU/ML INJECTABLE
08012016@34
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE/CITRULLINE+LIDOCAINE 75MG/75MG/150MG/50MG/100MG/10MG/ML INJECTABLE
08012016@35
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
08012016@41
Human
ESTRADIOL CYPIONATE 5MG/ML INJECTABLE
08022016@13
Vet
CYCLOSPORINE (A) OIL SOLUTION - (10ML) 2% OPHTHALMIC
08022016@20
Vet
PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE
08022016@27
Vet
DETOMIDINE HCL/XYLAZINE (20ML) 10MG/10MG/ML INJECTABLE
08022016@70
Vet
ESTRONE AQUEOUS 5MG/ML INJECTABLE
08022016@8
Vet
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
08032016@12
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
08032016@17
Human
TRIMIX - (10ML) 30MG / 2MG / 20MCG INJECTABLE
08032016@34
Human
TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE
08032016@35
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
08032016@38
Human
GLUTAMINE/ARGININE/CARNITINE 25MG/100MG/200MG/ML INJECTABLE
08032016@42
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
08042016@13
Human
ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE
08042016@14
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
08042016@21
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
08042016@35
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE, LYOPHILIZED 15MG/5.4MG/75MG VIAL
08042016@39
Human
QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
08052016@1
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
08052016@11
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
08052016@12
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
08052016@13
Human
FLUNIXIN MEGLUMINE 50MG/ML INJECTABLE
08052016@47
Vet
DEXAMETHASONE SODIUM PHOSPHATE 24MG/ML (2.4%) INJECTABLE
08052016@65
Human
SERMORELIN ACETATE 28MG KIT
08052016@74
Human
DEXAMETHASONE SODIUM PHOSPHATE 24MG/ML (2.4%) INJECTABLE
08082016@45
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 20,000 UNIT VIAL VIAL
08082016@50
Human
NICOTINAMIDE ADENINE DINUCLEOTIDE (NADH) - LYOPHILIZED (P.F.) 100MG INJECTABLE
08082016@58
Human
CARNITINE/TAURINE/B12(M) (10ML VIAL) 15MG/15MG/1MG INJECTABLE
08082016@67
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
08082016@80
Human
QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
08092016@18
Human
METHIONINE/INOSITOL/CHOLINE/B12(M)CARN/CHROM/LYSINE/DMG 25/50/50/0.5/50/25MCG/25/25 INJECTABLE
08092016@19
Human
FLUNIXIN MEGLUMINE 50MG/ML INJECTABLE
08092016@57
Vet
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
08092016@6
Human
METHIONINE/INOSITOL/CHOLINE+B12(M) + CARNITINE 12.5MG/50MG/100MG/1MG/50MG/MLINJECTABLE
08102016@2
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE 08102016@22 Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE+LIDOCAINE 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE
08102016@24
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO *(10ML)*12.5/25/25/25/12.5/0.2/20MG/ML INJECTABLE
08102016@9
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE 15MG/5.4MG/75MG KIT
08112016@121
Human
GLUTATHIONE - 30ML 200MG/ML INJECTABLE
08112016@19
Human
METHYLCOBALAMIN 5,000MCG/ML INJECTABLE
08112016@22
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
08112016@4
Human
FLUNIXIN MEGLUMINE 50MG/ML INJECTABLE
08112016@7
Vet
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
08122016@1
Human
NADH/CARNITINE/TAURINE/B12(M) - KIT 100MG NADH / 150MG/150MG/10MG KIT
08122016@103
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
08122016@3
Human
QUAD2 (2ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
08152016@17
Human
TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE
08152016@3
Human
CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 10,000 UNIT VIAL VIAL
08152016@40
Human
TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE
08162016@1
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/MLINJECTABLE
08162016@10
Human
CARNITINE-L 250MG/ML INJECTABLE
08172016@1
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
08172016@13
Human
INDOCYANINE GREEN, LYOPHILIZED (P.F.) 15MG VIAL
08172016@45
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
08172016@5
Human
FLUORESCEIN/INDOCYANINE, LYOPHILIZED (P.F.) 400MG/15MG VIAL INJECTABLE
08172016@55
Human
GLUTAMINE/ARGININE/CARNITINE 25MG/100MG/200MG/ML INJECTABLE
08182016@11
Human
TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE
08182016@26
Human
TRIMIX - (5ML) 30MG/2MG/20MCG INJECTABLE
08182016@27
Human
ESTRONE AQUEOUS 5MG/ML INJECTABLE
08182016@7
Vet
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
08192016@10
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE/CITRULLINE+LIDOCAINE 75MG/75MG/150MG/50MG/100MG/10MG/ML INJECTABLE
08192016@11
Human
CHORIONIC GONADOTROPIN + B12 10,000 UNIT KIT
08192016@110
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
08192016@39
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
08192016@45
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
08192016@47
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
08222016@15
Human
MEDROXYPROGESTERONE ACETATE 200MG/ML INJECTABLE
08222016@18
Vet
METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE
08222016@6
Human
TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE
08232016@2
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
08232016@24
Human
SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT
08232016@32
Human
INDOCYANINE GREEN - KIT 15MG INJECTABLE
08232016@42
Human
METHIONINE/INOSITOL/CHOLINE/B12(M)CARN/CHROM/LYSINE/DMG 25/50/50/0.5/50/25MCG/25/25 INJECTABLE
08232016@5
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
08242016@33
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
08242016@41
Human
ARGININE HCL 100MG/ML INJECTABLE
08252016@10
Human
ARGININE HCL 100MG/ML INJECTABLE
08252016@17
Human
CARNITINE-L 250MG/ML INJECTABLE
08252016@20
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE+LIDOCAINE 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE
08252016@27
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
08252016@3
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
08252016@34
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
08262016@2
Human
TRI-TEST 200 (CEP) 200MG/ML INJECTABLE
08262016@3
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
08262016@6
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
08262016@8
Human
TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE
08292016@23
Human
QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
08292016@25
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
08292016@26
Human
ARGININE HCL 100MG/ML INJECTABLE
08292016@3
Human
QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
08292016@5
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
08292016@6
Human
ARGININE HCL 100MG/ML INJECTABLE
08302016@65
Human
SERMORELIN ACETATE 28MG KIT
09062016@105
Human
SERMORELIN ACETATE 15MG KIT
09062016@114
Human
GLUTATHIONE - 30ML 200MG/ML INJECTABLE
09062016@24
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE+LIDOCAINE 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE
09062016@27
Human
CARNITINE-L 250MG/ML INJECTABLE
09062016@30
Human
METHYLCOBALAMIN 5,000MCG/ML INJECTABLE
09062016@32
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
09062016@33
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
09062016@74
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT
09062016@75
Human
SERMORELIN ACETATE/GHRP (2) 9MG/9MG KIT
09062016@92
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
09072016@10
Human
BIMIX - (10ML) 30MG/1MG INJECTABLE
09072016@18
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
09072016@19
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
09072016@20
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
09072016@21
Human
TRI2 - NR (2ML) 30MG/3MG/0.3MG INJECTABLE
09072016@22
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
09072016@7
Human
TRIMIX - (5ML) 30MG / 2MG / 40MCG INJECTABLE
09082016@25
Human
TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE
09082016@27
Human
TRIMIX - (5ML) 30MG / 1MG / 10MCG INJECTABLE
09082016@28
Human
QUAD4 (2ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
09082016@29
Human
TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE
09082016@31
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE
09082016@33
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE
09082016@35
Human
METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE
09082016@37
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 50MG/ML INJECTABLE
09082016@38
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 100MG/ML INJECTABLE
09082016@40
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
09092016@1
Human
B-COMPLEX + VIT C 20MG/ML INJECTABLE
09092016@11
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
09092016@15
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 7,500 UNIT VIAL VIAL
09092016@17
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL
09092016@20
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
09092016@35
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT
09092016@49
Human
ARGININE/CITRULLINE/ORNITHINE+LIDOCAINE 100MG/100MG/100MG/10MG/ML INJECTABLE
09092016@5
Human
SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT
09122016@138
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
09122016@17
Human
ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE
09122016@23
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
09122016@26
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
09122016@28
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE/CITRULLINE+LIDOCAINE 75MG/75MG/150MG/50MG/100MG/10MG/ML INJECTABLE
09122016@32
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
09122016@37
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE, LYOPHILIZED 15MG/5.4MG/75MG VIAL
09122016@54
Human
SODIUM BICARBONATE, MDV 8.4% INJECTABLE
09122016@9
Human
SERMORELIN ACETATE/GHRP (6) 6MG/3MG KIT
09132016@102
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
09132016@12
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
09132016@14
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
09132016@15
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
09132016@17
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO 12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
09132016@20
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
09132016@24
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
09132016@6
Human
SERMORELIN ACETATE/GHRP (2) 6MG/4.5MG KIT
09132016@98
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
09142016@17
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
09142016@27
Human
TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE
09142016@28
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
09142016@38
Human
ALPROSTADIL 40MCG/ML INJECTABLE
09142016@40
Human
TRIMIX - (5ML) 30MG/2MG/20MCG INJECTABLE
09142016@41
Human
John
-
Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance
For Immediate Release
September 20, 2016
Contact
Consumers
Quality Hotline
(800) 794-2360
Media
Announcement
Ocala, Florida – Wells Pharmacy Network (“WPN”) is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry (list below) due to the Food and Drug Administration’s (“FDA”) concern over a lack of sterility assurance.
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
The recalled products were used for a variety of indications. NO VIAL OR PORTION OF ANY LOT OF THESE MEDICATIONS HAS BEEN FOUND TO BE NON STERILE. All recalled products have a label that includes the name Wells Pharmacy Network, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine if their product is on the list. To date, no adverse events have been reported.
WPN takes the utmost care to ensure patient safety. All patients and providers that received any sterile compounded products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry, should take the following actions:
Discontinue use of the products;
Quarantine any unused product until further instructions are received on how to return the product; and Contact WPN at the Quality hotline at (800) 794-2360 Monday through Friday, between 9:00 am and 6:00 pm EST or email at WPNQuality@wellsrx.com to discuss the return of any unused sterile product.
Customers with questions regarding this recall can contact WPN at the Quality hotline at (800) 794-2360 Monday through Friday between 9:00 am and 6:00 pm EST or email at WPNQuality@wellsrx.com. Customers should contact their physician, healthcare provider, or veterinarian if they have experienced any problems that may be related to using these products. Providers who have dispensed any sterile products prepared between February 22, 2016 and September 14, 2016 to a patient(s) for use outside of the provider’s office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.
Adverse reactions or quality problems experienced with the use of these products in humans or animals may be reported to FDA in the following ways:
For adverse events in Humans please use FDA’s MedWatch Adverse Event Reporting program
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For reporting animal adverse drug events, please follow the link to the FORM FDA 1932a found at: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm
This recall is being conducted with the knowledge of and in cooperation with the FDA.
Again, WPN’s primary concern is your safety and WPN is taking this action out of an abundance of caution. Thank you for your support.
List of products to be recalled:
Drug
Lot #
Animal Type
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
03282016@10
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
03282016@16
Human
ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE
03282016@22
Human
TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE
03282016@3
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
03282016@6
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
03292016@12
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
03292016@3
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
03292016@5
Human
NICOTINAMIDE ADENINE DINUCLEOTIDE (NADH) - LYOPHILIZED (P.F.) 100MG INJECTABLE
03302016@13
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
03302016@4
Human
ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE
03302016@5
Human
TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE
03302016@6
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
03302016@8
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML) 15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
03302016@9
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
03312016@1
Human
ALPROSTADIL - (5ML) 20MCG/ML INJECTABLE
03312016@6
Human
TRIMIX - (10ML) 30MG / 2MG / 20MCG INJECTABLE
03312016@7
Human
QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
03312016@8
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (10ML) 210MG/ML INJECTABLE
03312016@9
Human
TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE
04012016@2
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE
04012016@4
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
04012016@7
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
04012016@9
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
04042016@10
Human
TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE
04042016@2
Human
TRIMIX WITH ATROPINE (2ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE
04042016@22
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
04042016@30
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
04042016@7
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
04052016@1
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 50MG/ML INJECTABLE
04052016@4
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
04052016@5
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
04062016@106
Human
SERMORELIN ACETATE/GHRP (2) 6MG/4.5MG KIT
04062016@170
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
04062016@3
Human
SODIUM BICARBONATE, MDV 8.4% INJECTABLE
04062016@4
Human
METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE
04062016@5
Human
HISTRELIN ACETATE, LYOPHILIZED 5.5MG INJECTABLE
04062016@6
Vet
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
04062016@7
Human
TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE
04072016@10
Human
TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE
04072016@13
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML) 15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
04072016@15
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT
04072016@19
Human
QUAD4 (2ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
04072016@8
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
04072016@85
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
04082016@3
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
04082016@4
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
04082016@6
Human
PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE
04082016@7
Vet
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
04112016@10
Human
TRIMIX WITH ATROPINE (10ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE
04112016@13
Human
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE
04112016@16
Human
VITAMIN D3 IN SESAME OIL (5ML) 100,000 IU/ML INJECTABLE
04112016@23
Human
TRIMIX / ATROPINE (10ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
04112016@6
Human
TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE
04112016@8
Human
TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE
04122016@1
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
04122016@17
Human
TRIMIX (10ML) 30MG/3MG/100MCG INJECTABLE
04122016@18
Human
TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE
04122016@19
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
04122016@2
Human
TRI-TEST 200 (CEP) 200MG/ML INJECTABLE
04122016@4
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
04122016@76
Human
TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE
04132016@1
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
04132016@14
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
04132016@32
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
04132016@69
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
04132016@8
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL
04132016@91
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 20,000 UNIT VIAL VIAL
04132016@96
Human
MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC
04142016@107
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
04142016@112
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
04142016@14
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
04142016@15
Human
QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
04142016@16
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
04142016@2
Human
SERMORELIN ACETATE 28MG KIT
04142016@28
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
04142016@34
Human
SERMORELIN ACETATE 15MG KIT
04142016@43
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE
04142016@5
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
04142016@7
Human
SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT
04152016@149
Human
ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE
04152016@2
Human
SERMORELIN ACETATE/GHRP (2) 9MG/9MG KIT
04152016@21
Human
METHYLCOBALAMIN 5,000MCG/ML INJECTABLE
04152016@3
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
04152016@5
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
04182016@10
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
04182016@33
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
04182016@37
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
04182016@4
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
04182016@49
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE
04182016@6
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
04192016@5
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO *(10ML)*12.5/25/25/25/12.5/0.2/20MG/ML INJECTABLE
04192016@7
Human
METHIONINE/INOSITOL/CHOLINE+B12(M) + CARNITINE 12.5MG/50MG/100MG/1MG/50MG/MLINJECTABLE
04192016@8
Human
VITAMIN D3 IN SESAME OIL 50,000 IU/ML INJECTABLE
04202016@1
Human
ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE
04202016@2
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
04202016@4
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
04202016@5
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
04202016@56
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE, LYOPHILIZED 15MG/5.4MG/75MG VIAL
04202016@8
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE
04212016@149
Human
TRIMIX - (5ML) 30MG / 1MG / 10MCG INJECTABLE
04212016@17
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
04212016@19
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 100MG/ML INJECTABLE
04212016@5
Human
SERMORELIN ACETATE 9MG KIT
04212016@55
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
04222016@10
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
04222016@4
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 50MG/ML INJECTABLE
04222016@6
Human
ALPROSTADIL 20MCG/ML INJECTABLE
04222016@8
Human
QUAD2 (2ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
04222016@9
Human
CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 10,000 UNIT VIAL VIAL
04252016@168
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
04252016@17
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
04252016@2
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
04252016@21
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
04252016@4
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 7,500 UNIT VIAL VIAL
04262016@25
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
04262016@3
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO 12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
04262016@4
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
04262016@56
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
04272016@4
Human
QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
04272016@8
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
04272016@9
Human
DETOMIDINE HCL/XYLAZINE (20ML) 10MG/10MG/ML INJECTABLE
04272016@94
Vet
TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE
04282016@1
Human
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE
04282016@3
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
04282016@41
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
04282016@43
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO 12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
04282016@5
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE
04282016@7
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
04292016@10
Human
B-COMPLEX + VIT C 20MG/ML INJECTABLE
04292016@11
Human
TRIMIX - (5ML) 30MG / 1MG / 10MCG INJECTABLE
04292016@16
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
04292016@3
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE
04292016@5
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
04292016@80
Human
METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE
04292016@93
Human
BUPRENORPHINE HCL 0.6MG/ML INJECTABLE
05022016@1
Human
MEDROXYPROGESTERONE ACETATE 200MG/ML INJECTABLE
05022016@11
Vet
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
05022016@14
Human
MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC
05022016@160
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
05022016@189
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE
05022016@4
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE
05022016@6
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
05022016@9
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
05032016@1
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
05032016@11
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
05032016@15
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
05032016@2
Human
TRIMIX (10ML VIAL) 17.65MG/0.59MG/5.9MCG INJECTABLE
05042016@16
Human
CHORIONIC GONADOTROPIN + B12 10,000 UNIT KIT
05042016@162
Human
TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE
05042016@18
Human
TRI2 - NR (2ML) 30MG/3MG/0.3MG INJECTABLE
05042016@19
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05042016@20
Human
TRI-TEST 200 (CEP) 200MG/ML INJECTABLE
05042016@3
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
05042016@6
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
05052016@134
Human
ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE
05052016@2
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05052016@33
Human
TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE
05052016@4
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
05052016@5
Human
VITAMIN D3 IN SESAME OIL 50,000 IU/ML INJECTABLE
05052016@6
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
05062016@3
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
05062016@4
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
05062016@5
Human
TRIMIX - (5ML) 30MG / 2MG / 40MCG INJECTABLE
05062016@9
Human
ESTRADIOL CYPIONATE 5MG/ML INJECTABLE
05092016@12
Vet
ALPROSTADIL 40MCG/ML INJECTABLE
05092016@14
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
05092016@4
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
05092016@57
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
05092016@6
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
05102016@1
Human
TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE
05102016@10
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 100MG/ML INJECTABLE
05102016@123
Human
TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE
05102016@18
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
05102016@54
Human
GLUCOSAMINE SULFATE 20% INJECTABLE
05102016@6
Vet
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
05112016@23
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
05112016@24
Human
PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE
05112016@3
Vet
PENTOSAN SODIUM POLYSULFATE 250MG/ML INJECTABLE
05112016@8
Vet
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05122016@11
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05122016@12
Human
TRIMIX - (5ML) 30MG / 2MG / 40MCG INJECTABLE
05122016@163
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
05122016@180
Human
ARGININE HCL 100MG/ML INJECTABLE
05122016@3
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO *(10ML)*12.5/25/25/25/12.5/0.2/20MG/ML INJECTABLE
05122016@6
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
05122016@7
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05132016@19
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05132016@21
Human
VITAMIN D3 IN SESAME OIL (5ML) 100,000 IU/ML INJECTABLE
05132016@3
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO *(10ML)*12.5/25/25/25/12.5/0.2/20MG/ML INJECTABLE
05132016@7
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
05132016@9
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL
05162016@136
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
05162016@14
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
05162016@16
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
05162016@2
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE 15MG/5.4MG/75MG KIT
05162016@37
Human
ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE
05162016@5
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
05162016@6
Human
METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE
05172016@1
Human
SERMORELIN ACETATE/GHRP (6) 6MG/3MG KIT
05172016@229
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
05172016@4
Human
BIMIX - (10ML) 30MG/1MG INJECTABLE
05172016@44
Human
ALPROSTADIL 40MCG/ML INJECTABLE
05172016@48
Human
ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE
05172016@5
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
05172016@6
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
05182016@1
Human
QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
05182016@15
Human
TRIMIX - (5ML) 30MG / 1MG / 10MCG INJECTABLE
05182016@16
Human
TRIMIX - (5ML) 30MG/2MG/20MCG INJECTABLE
05182016@17
Human
SERMORELIN ACETATE 15MG KIT
05182016@173
Human
SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT
05182016@176
Human
TRIMIX WITH ATROPINE (2ML VIAL) 30MG/3MG/300MCG/0.2MG/ML INJECTABLE
05182016@18
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
05182016@2
Human
SERMORELIN ACETATE/GHRP (2) 9MG/9MG KIT
05182016@215
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
05182016@3
Human
SERMORELIN ACETATE 28MG KIT
05182016@51
Human
METHYLCOBALAMIN 5,000MCG/ML INJECTABLE
05192016@1
Human
TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE
05192016@22
Human
TRIMIX - (10ML) 30MG / 2MG / 20MCG INJECTABLE
05192016@23
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
05192016@3
Human
ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE
05192016@7
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
05192016@84
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO 12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
05192016@9
Human
FLUORESCEIN/INDOCYANINE, LYOPHILIZED (P.F.) 400MG/15MG VIAL INJECTABLE
05202016@4
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
05202016@55
Human
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE
05202016@6
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05202016@71
Human
ALPROSTADIL 20MCG/ML INJECTABLE
05202016@85
Human
SODIUM BICARBONATE, MDV 8.4% INJECTABLE
05232016@120
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
05232016@17
Human
TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE
05232016@2
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 100MG/ML INJECTABLE
05232016@21
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
05232016@22
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 20,000 UNIT VIAL VIAL
05242016@1
Human
BIMIX - (10ML) 30MG/1MG INJECTABLE
05242016@11
Human
MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC
05242016@128
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
05242016@13
Human
MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC
05242016@131
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
05242016@135
Human
METHIONINE/INOSITOL/CHOLINE+B12(M) + CARNITINE 12.5MG/50MG/100MG/1MG/50MG/ML INJECTABLE
05242016@15
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
05242016@2
Human
CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 10,000 UNIT VIAL VIAL
05252016@117
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
05252016@2
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO12.5/25/25/25MG/12.5MG/0.2MG/20MG INJECTABLE
05252016@25
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE, LYOPHILIZED 15MG/5.4MG/75MG VIAL
05252016@33
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
05262016@1
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
05262016@12
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
05262016@13
Human
SERMORELIN ACETATE 28MG KIT
05262016@146
Human
TRIMIX - (5ML) 30MG / 2MG / 40MCG INJECTABLE
05262016@15
Human
TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE
05262016@2
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
05262016@24
Human
TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE
05262016@3
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
05262016@32
Human
SERMORELIN ACETATE/GHRP (2) 3MG/4.5MG KIT
05272016@100
Human
FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/3MG/60MCGINJECTABLE
05272016@18
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
05272016@2
Human
METHOCARBAMOL 100MG/ML INJECTABLE
05272016@3
Vet
CEFTAZIDIME, LYOPHILIZED 2.25% VIAL
05272016@47
Human
MEDROXYPROGESTERONE ACETATE 200MG/ML INJECTABLE
05272016@5
Vet
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT
05272016@55
Human
SERMORELIN ACETATE/GHRP (2) 6MG/4.5MG KIT
05272016@67
Human
SERMORELIN ACETATE/GHRP (6) 3MG/3MG KIT
05272016@73
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE, LYOPHILIZED 15MG/5.4MG/75MG VIAL
05312016@47
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
05312016@5
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 50MG/ML INJECTABLE
05312016@8
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
06012016@11
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
06012016@44
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06012016@6
Human
TRI-TEST 200 (CEP) 200MG/ML INJECTABLE
06012016@8
Human
B-COMPLEX + VIT C 20MG/ML INJECTABLE
06012016@9
Human
TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE
06022016@13
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
06022016@5
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MGINJECTABLE
06022016@7
Human
SERMORELIN ACETATE/GHRP (6) 6MG/3MG KIT
06032016@136
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
06032016@2
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
06032016@3
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
06032016@41
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 7,500 UNIT VIAL VIAL
06032016@44
Human
ARGININE/CITRULLINE/ORNITHINE+LIDOCAINE 100MG/100MG/100MG/10MG/ML INJECTABLE
06032016@7
Human
VITAMIN D3 IN SESAME OIL 50,000 IU/ML INJECTABLE
06062016@1
Human
CEFTAZIDIME, OPHTHALMIC KIT 2.25% KIT
06062016@118
Human
CHORIONIC GONADOTROPIN + B12 10,000 UNIT KIT
06062016@122
Human
VITAMIN D3 IN SESAME OIL (5ML) 100,000 IU/ML INJECTABLE
06062016@7
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
06072016@17
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
06072016@18
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
06072016@3
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
06072016@32
Human
FLUORESCEIN/INDOCYANINE, (P.F.) 400MG/15MG VIAL KIT
06082016@133
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06082016@2
Human
ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE
06082016@44
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE
06082016@7
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
06082016@75
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
06082016@8
Human
TRIMIX - (10ML) 30MG / 2MG / 20MCG INJECTABLE
06082016@82
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
06092016@17
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
06092016@30
Human
TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE
06092016@4
Human
QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
06102016@13
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
06102016@2
Human
TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE
06102016@35
Human
ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE
06102016@6
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT
06102016@62
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
06102016@9
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
06132016@1
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
06132016@155
Human
PHENTOLAMINE/ALPROSTADIL 3MG/60MCG INJECTABLE
06132016@18
Human
METHYLCOBALAMIN 5,000MCG/ML INJECTABLE
06132016@23
Human
TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE
06132016@36
Human
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE
06132016@4
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
06132016@93
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
06142016@1
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06142016@148
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE
06142016@19
Human
TRI2 - NR (2ML) 30MG/3MG/0.3MG INJECTABLE
06142016@28
Human
BIMIX - (5ML) 30MG/1MG INJECTABLE
06142016@39
Human
QUAD2 (2ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
06142016@42
Human
TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE
06142016@43
Human
PENTOSAN SODIUM POLYSULFATE 250MG/ML INJECTABLE
06142016@47
Vet
SODIUM BICARBONATE, MDV 8.4% INJECTABLE
06142016@9
Human
PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE
06152016@1
Vet
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
06152016@15
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
06152016@22
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
06152016@57
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
06152016@7
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
06162016@129
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
06162016@13
Human
METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE
06162016@2
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
06162016@6
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06162016@9
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
06172016@120
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06172016@13
Human
SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT
06172016@142
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE 15MG/5.4MG/75MG KIT
06172016@161
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
06172016@3
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 7,500 UNIT VIAL VIAL
06202016@137
Human
TRIMIX 17.65MG/0.59MG/5.9MCG INJECTABLE
06202016@157
Human
TRIMIX (5ML) 30MG / 3MG / 60MCG INJECTABLE
06202016@162
Human
MEDROXYPROGESTERONE ACETATE 200MG/ML INJECTABLE
06202016@2
Vet
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
06212016@17
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
06212016@2
Human
TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE
06212016@21
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
06212016@42
Human
TRI-TEST 200 (CEP) 200MG/ML INJECTABLE
06212016@5
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE, LYOPHILIZED 15MG/5.4MG/75MG VIAL
06212016@80
Human
SERMORELIN ACETATE 9MG KIT
06222016@106
Human
SERMORELIN ACETATE/GHRP (6) 6MG/3MG KIT
06222016@121
Human
SERMORELIN ACETATE/GHRP (6) 6MG/3MG KIT
06222016@148
Human
METHIONINE/INOSITOL/CHOLINE+B12(M) + CARNITINE 12.5MG/50MG/100MG/1MG/50MG/ML INJECTABLE
06222016@28
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
06222016@30
Human
MIC/B12 (M)- (30ML) 15MG/50MG/100MG/1MG/ML INJECTABLE
06222016@42
Human
METHOCARBAMOL 100MG/ML INJECTABLE
06222016@7
Vet
TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE
06232016@12
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
06232016@13
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
06232016@147
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
06232016@23
Human
MEDROXYPROGESTERONE ACETATE 200MG/ML INJECTABLE
06232016@27
Vet
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL
06232016@49
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
06232016@70
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
06232016@74
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06232016@78
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
06242016@11
Human
SERMORELIN ACETATE/GHRP (2)/THEANINE 15MG/5.4MG/75MG KIT
06242016@135
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL
06242016@96
Human
TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE
06242016@97
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE
06272016@13
Human
VITAMIN D3 IN SESAME OIL (5ML) 100,000 IU/ML INJECTABLE
06272016@17
Human
QUAD4 (2ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
06272016@22
Human
ESTRONE AQUEOUS 5MG/ML INJECTABLE
06272016@29
Vet
TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE
06272016@8
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
06282016@31
Human
INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE
06282016@36
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
06282016@45
Human
MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE
06282016@71
Human
ESTRADIOL CYPIONATE 5MG/ML INJECTABLE
06282016@79
Vet
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
06282016@80
Human
METHIONINE/INOSITOL/CHOLINE/B12(M)CARN/CHROM/LYSINE/DMG 25/50/50/0.5/50/25MCG/25/25 INJECTABLE
06292016@10
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
06292016@2
Human
TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MGINJECTABLE
06292016@25
Human
ESTRONE AQUEOUS 5MG/ML INJECTABLE
06292016@5
Vet
GLUTAMINE/ORNITHINE/ARGININE/LYSINE+LIDOCAINE 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE
06292016@9
Human
TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE
06302016@1
Human
ALPROSTADIL 20MCG/ML INJECTABLE
06302016@4
Human
CARNITINE/TAURINE/B12(M) (10ML VIAL) 15MG/15MG/1MG INJECTABLE
06302016@90
Human
NICOTINAMIDE ADENINE DINUCLEOTIDE (NADH) - LYOPHILIZED (P.F.) 100MG INJECTABLE
06302016@95
Human
GLUTAMINE/ARGININE/CARNITINE 25MG/100MG/200MG/ML INJECTABLE
07012016@10
Human
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
07012016@112
Human
METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE
07012016@18
Human
TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE
07012016@22
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE
07012016@32
Human
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE
07052016@1
Human
DMSO W/LIDOCAINE 50%/0.5% SOLUTION
07052016@12
Human
SERMORELIN ACETATE 15MG KIT
07052016@148
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CAR+ARG+CHR+LIDO *(10ML)*12.5/25/25/25/12.5/0.2/20MG/ML INJECTABLE
07052016@19
Human
TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE
07052016@6
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
07052016@76
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE
07062016@10
Human
TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE
07062016@12
Human
SERMORELIN ACETATE/GHRP (2) & (6) 9MG/3.15MG/3.15MG KIT
07062016@156
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+LIDO 20MG/40MG/50MG/10MG/ML INJECTABLE
07062016@19
Human
QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE
07062016@29
Human
QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE
07062016@46
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE
07062016@7
Human
ARGININE HCL 100MG/ML INJECTABLE
07072016@15
Human
PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE
07072016@7
Vet
MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE
07072016@94
Human
DEXAMETHASONE SOD. PHOSPHATE 200MG/ML INJECTABLE
07082016@25
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
07082016@79
Human
TRIMIX - (5ML) 30MG / 2MG / 40MCG INJECTABLE
07082016@9
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
07112016@11
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
07112016@5
Human
BUPRENORPHINE HCL 0.6MG/ML INJECTABLE
07122016@144
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE
07122016@20
Human
QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
07122016@21
Human
TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE
07122016@40
Human
QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
07122016@41
Human
QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE
07122016@42
Human
METHYLCOBALAMIN 5,000MCG/ML INJECTABLE
07132016@10
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 100MG/ML INJECTABLE
07132016@18
Human
TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE
07132016@25
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+LIDO 20MG/40MG/50MG/10MG/ML INJECTABLE
07132016@5
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL
07132016@68
Human
ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE
07142016@28
Human
CYCLOSPORINE (A) OIL SOLUTION - (10ML) 2% OPHTHALMIC
07142016@35
Vet
MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC
07142016@64
Human
METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML)15MG/30MG/30MG/85MG/20MG/ML INJECTABLE
07152016@8
Human
TRIMIX (2ML VIAL) 30MG/1MG/25MCG INJECTABLE
07192016@24
Human
TRIMIX (2ML VIAL) 17.65MG/0.59MG/5.9MCG INJECTABLE
07192016@25
Human
TRIMIX (5ML VIAL) 30MG/1MG/25MCG INJECTABLE
07192016@26
Human
TRIMIX (2ML) 30MG / 3MG / 60MCG INJECTABLE
07192016@27
Human
ALPROSTADIL 40MCG/ML INJECTABLE
07192016@28
Human
TRIMIX WITH ATROPINE (5ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE
07192016@3
Human
TRIMIX (2ML VIAL) 30MG/3MG/100MCG INJECTABLE
07192016@5
Human
TRIMIX (5ML VIAL) 30MG/3MG/100MCG INJECTABLE
07192016@7
Human
TRIMIX WITH ATROPINE (10ML) 30MG/3MG/300MCG/0.2MG/ML INJECTABLE
07192016@8
Human
PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE
07202016@44
Vet
METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE
07202016@47
Human
ARGININE/CARNITINE/CITRULLINE/LIDOCAINE HCL 100MG/100MG/100MG/10MG/ML INJECTABLE
07202016@50
Human
METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE
07202016@55
Human
B-COMPLEX + VIT C 20MG/ML INJECTABLE
07212016@11
Human
METHIONINE/INOSITOL/CHOLINE/B12(M)/CARN/CHROM/LYSINE/DMG 25/50/50/0.5/50/25MCG/25/25 INJECTABLE
07212016@15
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE/CITRULLINE+LIDOCAINE 75MG/75MG/150MG/50MG/100MG/10MG/ML INJECTABLE
07212016@2
Human
LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE
07212016@8
Human
TRIMIX - (2ML) 30MG / 1MG / 10MCG INJECTABLE
07222016@15
Human
TRIMIX - (5ML) 30MG/2MG/20MCG INJECTABLE 07222016@16 Human
CARNITINE-L 250MG/ML INJECTABLE
07222016@2
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL
07222016@26
Human
ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE 07252016@16 Human
TRI-TEST 200 (CEP) 200MG/ML INJECTABLE
07252016@22
Human
GLUTAMINE/ORNITHINE/ARGININE/LYSINE+LIDOCAINE 75MG/75MG/150MG/150MG/10MG/MLINJECTABLE
07252016@39
Human
GLUTATHIONE - 30ML 200MG/ML INJECTABLE
07252016@46
Human
METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE
07252016@52
Human
CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 7,500 UNIT VIAL VIAL
07252016@56
Human
TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE
07262016@29
Human
TRI2 - NR (2ML) 30MG/3MG/0.3MG INJECTABLE
07262016@34
Human
QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE
07262016@36
Human
TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE
07262016@47
Human
TRIMIX (10ML) 30MG / 3MG / 60MCG INJECTABLE
07262016@49
Human
John
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RFG Canada Inc. Recalls Meat and Poultry Pizza Products Distributed Without Benefit of Import Inspection
Class I Recall
086-2016
Health Risk: High
Sep 22, 2016
Congressional and Public Affairs
Benjamin A. Bell
(202) 720-9113
WASHINGTON, Sept. 22, 2016 – RFG Canada Inc., a Toronto, Ontario establishment, is recalling approximately 1,250 pounds of meat and poultry pizza products imported from Canada and not presented to FSIS for re-inspection upon entry to the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.
The self-rising chicken bacon ranch and thin crust pepperoni pizzas were produced in Canada on March 3 and August 17, 2016 and imported to the United States on/around Sept. 13, 2016. The following products are subject to recall:
View Labels PDF Only
*NOTE…I cannot get this link to work.
30.3 oz. packages of “WEIS Self-Rising Pizza; Chicken Bacon Ranch” containing the UPC code 041497028337 and Canada Establishment 411 and best by date MAY 16 2017.
20.2 oz. packages of “WEIS Thin Crust Pepperoni Pizza 3 Pack” containing the UPC code 041497026524 and Canada Establishment 411 and best by date DEC 01 2016.
The products subject to recall bear establishment number “Canada Est. 411.” These items were shipped to retail locations in Maryland, New York, and Pennsylvania.
The problem was discovered on Sept. 16, 2016, by the FSIS import inspector during routine monitoring of shipments destined for their assignment. On Sept. 20, 2016, FSIS confirmed that there was a failure to present shipment and the products were already in commerce without receiving FSIS re-inspection upon entry to the United States.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and media with questions about the recall can contact Joe Ricci, Chief Executive Officer, at (416) 798-9900 ext. 221.
John
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Extortion Scam
New Drug Info Rounds Video
Have you heard about the scam where individuals pose as FDA agents and threaten jail, deportation, or physical harm unless a fine or fee is paid? Know how to recognize and report this extortion scam. Watch FDA’s new Extortion Scam video to learn more.
In this short video, FDA pharmacists discuss how to handle and report an extortion call from a fake FDA agent.
Other videos coming soon in the new series of Drug Info Rounds
include:
Combat Methamphetamine Epidemic Act
Drugs@FDA Tutorial
Drug Info Rounds are created and produced by pharmacists in FDA’s Center for Drug Evaluation and Research, Office of Communications, Division of Drug Information (DDI). DDI pharmacists respond to over 70,000 inquiries per year about FDA initiatives and regulated drugs from healthcare professionals, industry, and consumers. The Drug Info Rounds video series provides important and useful drug information to health care providers helping them be better clinicians and, ultimately, improving patient safety.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Blue Bell Ice Cream Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces Purchased From Outside Supplier Aspen Hills Due To Possible Health Risk
For Immediate Release
September 21, 2016
Contact
Consumers
Customer Service
979-836-7977
Media
media@bluebell.com
979-830-9830
Announcement
View Product Photos
Brenham, TX - Blue Bell Ice Cream is voluntarily recalling select products produced in its Sylacauga, Alabama, plant because they were made with a chocolate chip cookie dough ingredient supplied by a third party supplier Aspen Hills, Inc., due to the potential for it to contain Listeria monocytogenes.
Listeria monocytogenes which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
This recall covers the following products.
Blue Bell Ice Cream Half Gallons:
Code Dates
Blue Bell Chocolate Chip Cookie Dough
082618226
Blue Bell Cookie Two Step
080418222, 081818224
Blue Bell Ice Cream Pints:
Code Dates
Blue Bell Chocolate Chip Cookie Dough
081518242, 082418242
The products can be identified by the code date found on the bottom of the carton. The products produced with the chocolate chip cookie dough pieces were distributed in the following ten states Alabama, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia.
No illnesses have been reported to date. Blue Bell identified a potential problem through intensified internal testing and notified Aspen Hills. Aspen Hills then issued a voluntary recall of the products supplied to Blue Bell. Although our products in the marketplace have passed our test and hold program, which requires that finished product samples test negative for Listeria monocytogenes, Blue Bell is initiating this recall out of an abundance of caution. This recall is being conducted in cooperation with the FDA.
Consumers should not eat the recalled products and are encouraged to return them to the place of purchase for a full refund.
We continue to work closely with our regulatory agencies, and we remain committed to ensuring we are producing safe products for our consumers to enjoy. For more information, consumers with questions may call 979-836-7977, Monday-Friday 8 a.m.-5 p.m. CST.
John
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http://www.cpsc.gov/en/Recalls/2016/Infant-Carriers-Recalled/
Infant Carriers Recalled Due to Fall Hazard; Manufactured By Lenny Lamb
Recall date: SEPTEMBER 21, 2016
Recall number: 16-268
Recall Summary
Name of product: Buckle Onbu infant carriers
Hazard: The internal stitching on the infant carrier is missing, posing a fall hazard to children.
Consumer Contact:
Lenny Lamb toll-free at 877-487-1416 from 2 a.m. to 10 a.m. ET Monday through Friday; via email service@lennylamb.com or online at https://us.lennylamb.com/ and click on Recalls for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 900 (in addition, about 600 were sold in Canada)
Description
The Lenny Lamb Buckle Onbu is an infant carrier designed to strap the baby against the caregiver’s body at the hip. It is intended for children who can already sit unassisted. It is most commonly used for back carry. The woven 100% cotton carrier was sold in 83 different styles and in one standard size. It has an interior panel to adjust the width, padded shoulder straps and an adjustable hood. A label with the manufacture date between 05.2016 and 06.2016 is located on the back side of the shoulder area of the carrier.
Incidents/Injuries
None reported
Remedy
Consumers should immediately stop using the recalled carrier and contact Lenny Lamb to receive a full refund or a free replacement carrier.
Sold at
Online at 5 Minute Recess, Ashley Hesch Bibetts, Lenny Lamb, Savanna Brown and other online retailers from May 2016 through June 2016 for about $90.
Manufacturer(s)
Lenny Lamb, of Poland
Manufactured in
Poland
John
-
News Release
502 Boundary Blvd. Recalls Black Forest Ham Products Due To Possible Foreign Matter Contamination
Class II Recall 085-2016
Health Risk: Low
Sep 21, 2016
Congressional and Public Affairs
Julie Schwartz
(202) 720-9113
WASHINGTON, Sept. 21, 2016 – 502 Boundary Blvd. Inc., formerly known as Fletcher’s Fine Foods Ltd., an Algona, Wash., establishment, is recalling approximately 8,694 pounds of ham products that may be contaminated with extraneous materials, specifically rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were produced and packed by Sofina Foods, a London, Ont., establishment, and exported to the United States on July 21, 2016. This product was only distributed to the United States.
The boneless, ready-to-eat ham items were produced on July 18, 2016. The following products are subject to recall:
View Label
6.02-lb. vacuum-sealed packages containing one “Fletcher’s Fine Foods CLASSICS Black Forest Brand Ham with Natural Juices.”
The products subject to recall bear “Product of Canada” and “Est. #337” on the label. The ready-to-eat ham products bear packaging code 16 OC 2016. These items were shipped to Costco and Sam’s Club establishments and distribution centers in Alaska, Utah, and Washington.
The problem was discovered when a retail location received a consumer complaint regarding the Black Forest Ham product. The consumer reported having found various sized pieces of what appeared to be rubber material embedded in the product.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact the Consumer Call Centre at 1-(855)-763-4621. Media with questions about the recall can contact Daniele Dufour, Senior Director, Communications and Public Relations, at (905) 747-3322 Ext. 2118.
John
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http://www.cpsc.gov/en/Recalls/2016/Denon-Recalls-Rechargeable-Battery-Packs/
Denon Recalls Rechargeable Battery Packs Due to Fire and Burn Hazards
Recall date: SEPTEMBER 20, 2016
Recall number: 16-267
Recall Summary
Name of product: HEOS 1 Go Pack rechargeable battery packs
Hazard: The battery can overheat, posing a fire and burn hazards.
Consumer Contact:
Denon toll-free at 844 -759-1987 from 10 a.m. to 10 p.m. ET Monday through Friday and 12 p.m. to 8 p.m. ET on Saturday or online at https://usa.denon.com and click on “Product Recall Information” at the bottom of the page
Recall Details
In conjunction with
Canada Flag
Units
About 3,400 (in addition, 240 were sold in Canada)
Description
This recall involves Denon’s HEOS 1 Go Pack lithium-ion rechargeable battery packs for wireless speakers. Only HEOS 1 Go Packs with a 10-character alpha-numeric serial number beginning with 5 or 601G91 and ending with 3517 through 4004 are included in the recall; the battery packs are black or white, hexagon-shaped and have four blue LED lights and a power button. HEOS, the model and serial numbers are printed on the bottom. Only the speaker battery is being recalled.
Incidents/Injuries
None reported
Remedy
Consumers should immediately stop using the recalled battery packs and contact Denon for a free replacement battery pack, including shipping.
Sold at
Best Buy (Magnolia), Brookstone and online at BestBuy.com and Amazon.com from May 2015 through June 2016 for about $100.
Importer(s)
Denon Electronics (USA) LLC, of Mahwah, N.J.
Manufactured in
China
John
-
Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Apple Tree Goat Dairy Recalls Four Goat Cheeses Because of Possible Health Risk
For Immediate Release
September 20, 2016
Contact
Consumers
Apple Tree Goat Dairy
(717) 694-0146
Announcement
View Product Photos
Apple Tree Goat Dairy of Richfield, PA is recalling Feta cheese aged 60 days lot #836, Gouda Cheese aged 60 days Lot #426 Pasturized chevre Lot #816, in 5 lb. or 8 oz. and French Herb Chevre Lot #736 in 8 oz. Or 5 lb. because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product may have been distributed in Washington DC, New Jersey, Delaware, Maryland, and Virginia thru Lancaster co-op.
The Chevre lot #816 was in 8 oz. shrink wrapped bags, French herb chevre lot #736 was packaged in 8oz. Shrink bag. Both Chevre may also have been in 5 lb. plastic tubs. The Feta lot #836 with expiration 12/16 and Gouda lot 426 was a square block 8oz package or a 5 lb block, also shrink wrapped.
No illnesses have been reported to date.
The recall was the result of a routine sampling program by Pennsylvania Department of Agriculture. The samples collected by Pennsylvania were found to be contaminated with Listeria Monocytogenes. We are currently working with PA Department of Agriculture to resolve the issue.
Customers who have purchased this product are urged not to consume it, and to contact the place of purchase for a full refund. Consumers with questions may contact the Apple Tree Goat Dairy at 717-694-0146 Monday thru Friday 8:00am to 5:00pm EST. if no answer, please leave a message and we will return your call as soon as possible.
John
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News Release
Speedy Foods Recalls Chicken Spring Rolls Due To Misbranding And Undeclared Allergens
Class I Recall
084-2016
Health Risk: High
Sep 20, 2016
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
WASHINGTON, Sept. 20, 2016 – Speedy Foods, LLC, a Commerce City, Colo. establishment, is recalling approximately 920 pounds of chicken spring roll products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains eggs, a known allergen which is not declared on the product label.
The southwest chicken spring rolls items were produced on March 10, 2016 and Aug. 8, 2016. The following products are subject to recall:
Label PDF Only
75 oz. BROWN BOX packages containing 180 pieces of “WHOLE FRESH FOODS SOUTHWEST CHICKEN SPRING ROLLS” with a package code of 3-10-16 and a case code of 16151 on the upper right hand side of the case.
75 oz. BROWN BOX packages containing 180 pieces of “WHOLE FRESH FOODS SOUTHWEST CHICKEN SPRING ROLLS” with a package code of 08-08-2016 and a case code of 16151 on the upper right hand side of the case.
The products subject to recall bear establishment number “EST. P-7195” inside the USDA mark of inspection. These items were shipped to distributors in Colorado and Oklahoma.
The problem was discovered by FSIS inspection personnel while conducting routine label verification activities.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and media with questions about the recall can contact Brandon Barnes, president, at (303) 287-2856.
John
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Making care decisions for a person with dementia near the end of life can be hard for caregivers. Because people with advanced dementia can no longer communicate clearly, they cannot share their wishes and concerns. You may have to make treatment decisions based on the person’s comfort at one end of the spectrum and extending life or maintaining abilities for a little longer at the other.
You may want to ask the health care team:
How will the approach the doctor is suggesting affect the person's quality of life? Will it make a difference in comfort and well-being?
If considering home hospice for the person with dementia, what will be needed to care for him or her? Does the facility have special experience with people with dementia?
What can I expect as the disease gets worse?
Learn more about dementia at the end of life.
Share this important information with family and friends:
Twitter: #Caregivers—ask these questions when making end of life decisions for someone with #dementia: http://bit.ly/2d5yTiL
Facebook: Caregivers of people with dementia may have some tough end of life decisions to make for their loved ones. Check out this resource to learn more about weighing care choices, caregiver support, and some questions to ask about dementia care: http://bit.ly/2cESW9p
John
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News Release
Tucson Tamale Wholesale Company, LLC Recalls Beef Tamale Products Containing Meat Produced Without Benefit of Federal Inspection
Class I Recall
081-2016
Health Risk: High
Sep 16, 2016
Distribution List PDF
Congressional and Public Affairs
Sarah R. Lichtman
(202) 720-9113
WASHINGTON, Sept. 16, 2016 – Tucson Tamale Wholesale Company, LLC, a Tucson, Ariz. establishment, is recalling approximately 915 pounds of beef tamale products that contain meat produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The ready-to-eat beef tamale items were produced on various dates from Aug. 11, 2016 to Sept. 13, 2016. The following products are subject to recall:
View Labels PDF Only
Bulk boxes containing 10- or 11-oz packages of two “Tucson Tamale Red Chile Beef Tamales,” with packaging dates of 8/11/2016, 8/15/2016, 8/22/2016, 8/31/2016 and 9/13/2016, and with case and package codes 2016224, 2016228, 2016235, 2016244 and 2016257.
Bulk boxes containing 10- or 11-oz packages of two “Tucson Tamale Chipotle Beef Tamales,” with packaging dates of 8/16/2016, 9/1/2016 and 9/2/2016, and with case and package codes 2016229, 2016245 and 2016246.
Bulk boxes containing 10- or 11-oz packages of two “Tucson Tamale Chipotle Beef & Cheese Tamales,” with packaging dates of 8/16/2016, 8/25/2016, 8/29/2016 and 9/2/2016, and with case and package codes 2016229, 2016238, 2016242 and 2016246.
The products subject to recall bear establishment number “EST. M45860” inside the USDA mark of inspection. These items were distributed to the firm’s restaurants in Arizona. These items were sold to consumers either in restaurants (without packaging), in foil “to-go” containers or with the original packaging intact.
The problem was discovered by FSIS personnel during routine inspection activities.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and members of the media with questions about the recall can contact Todd Martin, Owner, Tucson Tamale Wholesale Company, LLC, at (520) 398-6282.
John
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http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=6569&z=58
Flu Season: CDC Says Do Not Use Nasal Spray Flu Vaccine
For the 2016-2017 season, CDC recommends use of the flu shot (inactivated influenza vaccine or IIV) and the recombinant influenza vaccine (RIV). The nasal spray flu vaccine (live attenuated influenza vaccine or LAIV) should not be used during 2016-2017. The 2016-2017 influenza vaccination recommendations are now available.
While current U.S. flu activity is low overall, in the past 2 weeks CDC has received reports of a small number of localized influenza outbreaks. This is not unusual for September. It is not possible to make any predictions about the timing or severity of the upcoming influenza season based on these outbreaks.
CDC recommends a yearly flu vaccine for everyone 6 months and older. You should try to get your flu vaccine anytime between now and the end of October, if possible. Flu vaccination can reduce flu illnesses and prevent flu-related hospitalizations. Flu vaccines have been updated for the 2016-2017 season. More than 60 million doses of seasonal influenza vaccine have been distributed at this time.
CDC also recommends that patients suspected of having influenza who are at high risk of flu complications or who are very sick with flu-like illness should receive prompt treatment with influenza antiviral drugs without waiting for confirmatory testing.
John
-
Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Kellogg Company Recalls Limited Number of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles Due to Potential Health Risk
For Immediate Release
September 19, 2016
Contact
Consumers
1-800-962-1413
Announcement
View Product Photos
Kellogg Company is voluntarily recalling approximately 10,000 cases of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles because they have the potential to be contaminated with Listeria monocytogenes. No other Eggo products are impacted by this recall.
Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The company has received no reports of illness to date but is taking this action as part of its commitment to the health and safety of the people who eat its foods.
Recalled product was distributed to customers and retailers in 25 states (CO, CT, DE, GA, IA, IL, IN, KS, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, PA, VA, VT, WI, WY). The affected product is:
Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles (see photo below)
Package Size: 10 Box Count (12.3 oz)
Package UPC Code: 38000 40370
With Best If Used By Date of: NOV 21 17 or NOV 22 17
The date code can be found on the side of the package.
The recall is a result of routine tests that the company conducts which identified the potential for contamination. As soon as the company learned of a potential concern, it moved quickly to identify any foods that might be impacted and resolve the issue.
Kellogg is asking that people who purchased affected product discard it and contact the company for a full refund. Consumers can call 1-800-962-1413, Monday through Friday, 9 a.m. – 6 p.m. ET or by visiting https://www.kelloggs.com/en_US/contact-us.html
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Ferrara Candy Issues Allergy Alert on Undeclared Peanuts and Wheat in Almond Supremes with a Best by Date of 4/22/2017
For Immediate Release
September 19, 2016
Contact
Consumers
Ferrara Candy Company
800-323-1768
Announcement
View Product Photos
Ferrara Candy Company has initiated a voluntary recall of Brach’s® 5 ounce Almond Supremes with a best by date of 4/22/2017 after discovering that some Brach’s® Almond Supremes packages may include Brach’s® Bridge Mix, a product that contains peanuts and wheat. No other Ferrara Candy Company products are affected.
People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. If you are a consumer and have purchased one of the affected products, please return the unopened product to your retailer for a full refund or replacement. If your package has been opened, you may still return the empty package to your local retailer for a full refund or replacement.
The affected product was distributed throughout retail stores in Florida, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, Nebraska, Ohio, South Carolina, Texas, Washington and Wisconsin. Recalled items include:
Item
Description
Item UPC Code
Date:
39733
Brach’s® Almond Supremes, 5oz
11300 3
97336G23CC33102
After discovering the issue, Ferrara Candy immediately investigated and determined that the packaging error was caused by an incorrect roll of packaging film being accidentally loaded in one of its manufacturing facilities. Ferrara Candy has moved quickly to locate the potentially affected product and has currently retrieved over half of it. To date, only six bags of Brach’s® Almond Supremes have been found to include Brach’s® Bridge Mix, and to date no illnesses have been reported in connection with this issue.
Consumers looking for additional information on the recall are encouraged to speak with one of Ferrara Candy Company’s representatives regarding this issue by calling the Company during normal business hours, Monday through Friday 8 a.m. to 5 p.m. CDT, at 800-323-1768.
About Ferrara Candy Company
Headquartered in Oakbrook Terrace, Ill., Ferrara Candy Company is a leading general line candy manufacturer, created by the merger of Ferrara Pan Candy Co. Inc. and Farley's & Sathers Candy Company, Inc. in 2012. The Company manufactures a robust portfolio of branded and private label confections that consumers love. For more information, please visit the company's website, www.ferrarausa.com.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Mei Shun Noodle, Inc. Issues Allergy Alert on Undeclared Shellfish and Soy in Rice Noodles
For Immediate Release
September 19, 2016
Contact
Consumers
1-312-842-6500
Announcement
View Product Photos
Mei Shun Noodle, Inc. of Chicago, IL, is recalling its 12 ounce packages of 6毛FIVE branded Rice Noodles. During inspection by the Illinois Department of Public Health, we found that some of the product was mislabeled. The products may contain dried, salted shrimp and soy, which are not included on the label. These ingredients may cause an adverse reaction for persons allergic to shrimp and/or shellfish and soy. Shrimp and/or shellfish and soy allergic symptoms may include vomiting, stomach cramps, indigestion, diarrhea, hives, shortness of breath, wheezing, cough, swelling, weak pulse, or dizziness. People who have an allergy or severe sensitivity to shellfish or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled "Rice Noodles" were distributed in Chicago area retail stores only.
The product comes in a 12 ounce, Styrofoam package marked with the label “6毛FIVE Rice Noodles” on the top and was distributed between 8/16/2016 and 8/17/2016. These are freshly produced noodles. See sample product and label below.
No illnesses have been reported to date in connection with this problem.
Production of the product has since been corrected.
Consumers who have purchased 12 ounce packages of "6毛FIVE Rice Noodles" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-312-842-6500 Monday through Friday 9AM-5PM CST.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Censea, Inc. Recalls Shrimp Product Because of Possible Health Risk
For Immediate Release
September 19, 2016
Contact
Consumers
Recall Hotline
888-312-5995
Announcement
Censea, Inc. is recalling its A-PAC 8/12 count Headless Shell on Black Tiger Shrimp, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product was distributed to wholesale, retail and restaurant locations in NY, NJ, MA, RI, CT, VA, KY, IL and TX.
The recalled product can be identified as follows:
Product Name: 8/12 Headless Shell On Black Tiger Frozen Shrimp
Origin: Vietnam
Case Pack: 6 x 4 pound block frozen (24 pound Master Carton) not labeled for retail sale
Brand: A-PAC
Date Code: 36009V
No other products or date codes are affected.
There have been no illnesses reported as a result of consuming these products to date, and the product is being recalled in an abundance of caution after testing by the Arizona Department of Health Services of this not-ready-to-eat product indicated the presence of Salmonella. Affected shrimp are raw and are must be fully cooked before consumption.
If you are in possession of this product you should discard it, but retain proof of purchase information (such as a purchase receipt or photo of the product packaging) and contact Censea for a full refund.
Contact: We have setup a hotline to deal with this issue. The phone number for the hotline is 888-312-5995 and it is available Monday through Friday 7 AM to 7 PM Central Standard Time. You may also contact Aaron Breen by e-mail at aaron@censea.com.
John
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News Release
MIH Marketing and Sales Recalls Meat and Poultry Products Due To Insanitary Conditions
Class I Recall
079-2016
Health Risk: High
Sep 10, 2016
Distribution List PDF
Congressional and Public Affairs
Nina Anand
(202) 720-9113
WASHINGTON, Sept. 10, 2016 – MIH Marketing and Sales, a Beebe, AR. establishment, is recalling approximately 662,049 pounds of various meat and poultry products that were stored under insanitary conditions, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw chicken breast fillet, chicken thigh, chicken drum, chicken wing, and chicken tender items were produced by various federal establishments and sold at 17 retail stores located in Arkansas between April 10, 2016 and September 10, 2016. These products were in clear packages weighting approximately 5 pounds each.
Products were sold at the following locations:
Edwards Food Giant #19 Forrest City, AR;
Edwards Cash Saver #3473 Little Rock, AR;
Edwards Food Giant #37 Marianna, AR;
Edwards Good Giant #3474 Little Rock, AR;
Edwards Food Giant #1710 Harrisburg, AR;
Edwards Food Giant #3475 Little Rock, AR;
Edwards Food Giant #3444 Bryant, AR;
Edwards Cash Saver #3476; Edwards Cash Saver #3442 and Edwards Food Giant #3477;
Knight’s Super Foods, Beebe AR;
Knight’s Super Foods, Babot, AR.
In addition, various retail meat and poultry products sold at Chicken City Retail stores are being recalled. These products are in clear retail bags with a sales sticker that include the Sell-By Date between October 30, 2016 and March 19, 2017. The Chicken City Retail Stores that are recalling all meat and poultry products are located in Whitehall, AR; Jonesboro, AR; Conway, AR; Searcy, AR Marion, AR; North Little Rock, AR and Brinkley, AR.
The problem was discovered while the FSIS Office of Investigation, Enforcement and Audits (OIEA) was conducting routine food defense surveillance activities. The FSIS OIEA investigator discovered that the product was being stored under insanitary conditions, including rodent activity, in the storage areas of the property. FSIS and the establishment detained the remaining product. The items subsequently tested positive for alkaline phosphatase, demonstrating evidence of possible fecal matter.
There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and media with questions about the recall can contact John Hilger, Owner of MIH Marketing and Sales, at (501) -278-7041.
John
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FDA News Release
FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
For Immediate Release
September 19, 2016
Release
The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
“Patients with a particular type of Duchenne muscular dystrophy will now have access to an approved treatment for this rare and devastating disease,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In rare diseases, new drug development is especially challenging due to the small numbers of people affected by each disease and the lack of medical understanding of many disorders. Accelerated approval makes this drug available to patients based on initial data, but we eagerly await learning more about the efficacy of this drug through a confirmatory clinical trial that the company must conduct after approval.”
DMD is a rare genetic disorder characterized by progressive muscle deterioration and weakness. It is the most common type of muscular dystrophy. DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. The first symptoms are usually seen between three and five years of age, and worsen over time. The disease often occurs in people without a known family history of the condition and primarily affects boys, but in rare cases it can affect girls. DMD occurs in about one out of every 3,600 male infants worldwide.
People with DMD progressively lose the ability to perform activities independently and often require use of a wheelchair by their early teens. As the disease progresses, life-threatening heart and respiratory conditions can occur. Patients typically succumb to the disease in their 20s or 30s; however, disease severity and life expectancy vary.
Exondys 51 was approved under the accelerated approval pathway, which provides for the approval of drugs that treat serious or life-threatening diseases and generally provide a meaningful advantage over existing treatments. Approval under this pathway can be based on adequate and well-controlled studies showing the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit to patients (how a patient feels or functions or whether they survive). This pathway provides earlier patient access to promising new drugs while the company conducts clinical trials to verify the predicted clinical benefit.
The accelerated approval of Exondys 51 is based on the surrogate endpoint of dystrophin increase in skeletal muscle observed in some Exondys 51-treated patients. The FDA has concluded that the data submitted by the applicant demonstrated an increase in dystrophin production that is reasonably likely to predict clinical benefit in some patients with DMD who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. A clinical benefit of Exondys 51, including improved motor function, has not been established. In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children and the lack of available therapy.
Under the accelerated approval provisions, the FDA is requiring Sarepta Therapeutics to conduct a clinical trial to confirm the drug’s clinical benefit. The required study is designed to assess whether Exondys 51 improves motor function of DMD patients with a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
The most common side effects reported by participants taking Exondys 51 in the clinical trials were balance disorder and vomiting.
The FDA granted Exondys 51 fast track designation, which is a designation to facilitate the development and expedite the review of drugs that are intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. It was also granted priority review and orphan drug designation. Priority review status is granted to applications for drugs that, if approved, would be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation provides incentives such as clinical trial tax credits, user fee waiver and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.
The manufacturer received a rare pediatric disease priority review voucher, which comes from a program intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. This is the seventh rare pediatric disease priority review voucher issued by the FDA since the program began.
Exondys 51 is made by Sarepta Therapeutics of Cambridge, Massachusetts.
John
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News Release
Gallo Meats LLC. Recalls Sausage, Beef and Lamb Products Produced Without Benefit of Inspection
Class I Recall
083-2016
Health Risk: High
Sep 17, 2016
Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
WASHINGTON, Sept. 17, 2016 – Gallo Meats LLC., a Colville, Wash., establishment, is recalling approximately 82 pounds of various sausage, beef and lamb products that were produced without the benefit of federal inspection although a mark of inspection was applied to the products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The Italian sausage, beef and lamb items were produced on various dates between April 20 and July 27, 2016. The following products are subject to recall:
View Labels PDF Only
12-16 oz. cryovac packages of “HOT ITALIAN SAUSAGE” with a pack date of 04-20-16.
12-16 oz. cryovac packages of “GROUND LAMB” with a pack date of 06-07-16.
12-16 oz. cryovac packages of “BEEF FLANK STEAK” with a pack date of 07-22-16 or 07-27-16.
The products subject to recall bear establishment number “EST. 09334” inside the USDA mark of inspection. These items were sold to consumers in Washington state.
The problem was discovered on Sept. 14, 2016 when FSIS inspectors observed product that was marked with the USDA mark of inspection that was not produced during FSIS inspection.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and media with questions about the recall can contact Kim Gallo, Vice President, Gallo Meats LLC at (509) 684-3448.
John
Recall: Cow Ghee
in Pinching Pennies
Posted
http://www.fda.gov/Safety/Recalls/ucm522337.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Urgent Allergy Alert: “Vrindavan” Cow Ghee Recall due to Undeclared Milk Allergen
For Immediate Release
September 9, 2016
Contact
Consumers
Mahesh Maheshwari
(866) 777-7767
Announcement
View Product Photos
http://www.fda.gov/Safety/Recalls/ucm522337.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos
Sabji Mandi
72-30, 37th Avenue
Jackson Heights, NY 11378
Dear valued customer:
This is to inform you of our product recall involving:
“VRINDAVAN” COW GHEE - ENTIRE STOCK, SUPPLIED BEFORE SEPTEMBER 9TH, 2016 IN THE FOLLOWING SIZES PACKED IN CLEAR GLASS JARS.
2 fl. oz. (UPC #753642000999)
8 fl. oz. (UPC #753642001002)
16 fl. oz. (UPC #753642001002)
32 fl. oz. (UPC #753642001019)
64 fl. oz. (UPC #753642001033)
128 fl. oz. (UPC #753642001040)
See enclosed picture of the “VRINDAVAN” COW GHEE jar.
This voluntary recall has been initiated on September 9th, 2016 due to an undeclared milk allergen on “VRINDAVAN” COW GHEE labeling. Consumers who are allergic to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.
We encourage you to immediately examine your inventory and quarantine the entire stock of “VRINDAVAN” COW GHEE until September 9th, 2016. In addition, if you may have further distributed it, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Those who have purchased “VRINDAVAN” COW GHEE should return the product to its place of purchase for a full refund.
This recall should be carried out to the wholesale, retail, consumer and user level. Your assistance is appreciated and necessary to prevent a serious or life-threatening allergic reaction to consumers.
No allergic reaction has been reported to date.
This recall is being made with the knowledge of the Food and Drug Administration.
We ask you that you please complete and return the enclosed response form as soon as possible.
If you have any questions, call Mahesh Maheshwari at (866) 777-7767.
Mahesh Maheshwari
President
John