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http://www.cpsc.gov/en/Recalls/2016/Xenith-Recalls-Football-Helmets/
Xenith Recalls Football Helmets Due to Head Injury Hazard
Recall date: AUGUST 17, 2016
Recall number: 16-245
Recall Summary
Name of product: Football helmets
Hazard: The shells of the football helmets can crack, posing a risk of head injuries to football players.
Consumer Contact:
Xenith at 800-956-9022 from 9 a.m. to 6 p.m. ET Monday through Friday or online at www.xenith.com
and click on the “Helmet Shell Recall” link on the homepage for more information.
Recall Details
Units
About 5,900
Description
This recall involves Xenith Epic Varsity, X2 Varsity, X2E Varsity and Youth football helmets with a gloss or metallic-painted polycarbonate shell sold or factory-reconditioned between May 1, 2015 and March 18, 2016. The helmets were sold in multiple sizes depending on the model, and in varying colors and custom-paint designs. They have a facemask and a chin cup, available in different styles and varying colors, and may have an optional eye shield. The serial number is printed on a white sticker inside the top of the helmet. A complete list of the serial numbers included in this recall is available at www.xenith.com/recall.
Incidents/Injuries
The firm received 29 reports of cracking helmets; no injuries reported.
Remedy
Football players should immediately stop using the recalled helmets. Players, coaches and parents should contact Xenith to receive a free new replacement helmet.
Sold at
Through team dealers and direct school sales, and at BSN, Buddy’s All Stars, Carey’s Sporting Goods, End Zone Sports and Sports, Inc. and other stores nationwide and online at Eastbay.com, Footlocker.com, SafetyFirstSports.com, SportsUnlimitedInc.com and Xenith.com from May 2015 through March 2016 for between $140 and $400.
Manufacturer(s)
Xenith LLC, of Detroit, Mich.
Manufactured in
U.S.
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.
Sage Products Expands Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination
For Immediate Release
August 12, 2016
Contact
Consumers
Sage Products Customer Service
1-800-421-6556
Media
Michael Nygren
Director of Marketing Communications
815-455-4700
Announcement
View Product Photos
http://www.fda.gov/Safety/Recalls/ucm514358.htm#recall-photos
Cary, IL, Sage Products announced today it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia.
Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. To date, no adverse events have been reported associated with the recalled products, which were distributed to distributors and healthcare facilities in the United States. The product, Comfort Shield Barrier Cream Cloths is a non-sterile, topical skin protectant used to treat and prevent moisture associated skin irritation caused by urine and/or stool exposure. The package contains single-use, disposable cloths. This recall affects the following lots of Comfort Shield Barrier Cream Cloths:
Product Code
NDC Number
Lot Number
Expiration Date
7503
53462-915-50
53957
3/6/2018
7905
53462-915-80
55781
6/19/2018
Sage Products notified its distributors and healthcare facilities by letter, and they were provided instructions to discontinue use and return product to Sage Products. The affected lots were distributed to customers between March 31 - June 8, 2016 and July 18 - July 19, 2016.
Customers who received affected products should discontinue use of the affected products and return them to Sage Products for credit by contacting Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. to 5:00 p.m., Central Time.
Customers with questions regarding this recall, or requiring replacement product, can call Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. to 5:00 p.m., Central Time.Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Media Contacts: Michael Nygren
Director of Marketing Communications
815-455-4700 mnygren@sageproducts.com
# # #
About Sage Products
Since 1971, Sage Products has successfully developed and produced innovative prevention products that have significantly improved outcomes for patients and clinicians, while improving efficiency and profitability for healthcare facilities. In 2016, Sage was acquired by Stryker Corporation and is a business within the Stryker Medical Division. Sage is a leading developer of products used to prevent hospital-acquired conditions such as skin injury due to incontinence, pressure ulcers, surgical site infections and healthcare worker injury. To learn more, visit www.sageproducts.com
Original Release
http://www.fda.gov/Safety/Recalls/ucm514358.htm
John
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Public Notification: Master Zone 1500 contains hidden drug ingredients
[8-16-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Master Zone 1500, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.
FDA laboratory analysis confirmed that Master Zone 1500 contains sildenafil and tadalfil, which are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
John
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FDA Approves Nocita, a New Animal Drug for Local Post-operative Pain in Dogs
August 16, 2016
The U.S. Food and Drug Administration today announced the approval of Nocita (bupivacaine liposome injectable suspension), a new animal drug that provides post-operative pain relief for knee surgery in dogs. Post-operative pain occurs with any surgical procedure. Managing pain after surgical procedures ensures the comfort of the dog as they heal from surgery.
Nocita is a liposome formulation of bupivacaine, an amide local anesthetic that produces local post-operative analgesia directly at the surgical site. Nocita is administered as a single treatment into the tissue layers during surgical closure. The drug offers bupivacaine during time-release at the surgical site, providing local post-operative relief for up to 72 hours after surgery.
The most common adverse reactions include discharge and inflammation at the surgical site, vomiting, abnormal urine, increased alkaline phosphatase (a liver enzyme) and fever. This product must be prescribed and administered by a licensed veterinarian because professional expertise is needed to administer the product correctly and safely during the surgery.
Nocita should not be combined with other amide local anesthetics. Gloves should be worn when handling or administering Nocita.
The application for Nocita is sponsored by Aratana Therapeutics.
Contact FDA
240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine
7519 Standish Place, HFV-1
Rockville, MD 20855
John
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Public Notification: Natural Eruption contains hidden drug ingredient
[8-16-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Natural Eruption, a product promoted and sold for weight loss and increasing energy on various websites and in some retail stores.
FDA laboratory analysis confirmed that Natural Eruption contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
John
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Public Notification: One More Knight 1750 contains hidden drug ingredients
[8-16-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use One More Knight 1750, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.
FDA laboratory analysis confirmed that One More Knight 1750 contains tadalfil and dapoxetine. Tadalafil is the active ingredients in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
John
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Public Notification: Love4Long contains hidden drug ingredient
[8-16-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Love4Long, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.
FDA laboratory analysis confirmed that Love4Long contains sildenafil. Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
John
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News Release
Bar-S Foods Company Recalls Chicken and Pork Hot Dog and Corn Dog Products Due to Possible Listeria Contamination
Class I Recall
061-2016
Health Risk: High
Jul 19, 2016
Distribution List PDF
Congressional and Public Affairs
Maria Machuca
(202) 720-9113
WASHINGTON, July 19, 2016 – Bar-S Foods Company, an Altus, Okla. establishment, is recalling approximately 372,684 pounds of chicken and pork hot dog and corn dog products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The ready-to-eat, chicken and pork hot dog and corn dog items were produced on July 10, 11, 12, and 13, 2016. The following products are subject to recall:
View Labels PDF Only
16-oz/1-lb. packages of “BAR-S Classic BUN LENGTH Franks MADE WITH CHICKEN, PORK ADDED” with “Use By” date of 10/11/2016 and case code 209.
12-oz. packages of “BAR-S CLASSIC Franks MADE WITH CHICKEN, PORK ADDED” with package code 6338, “Use By” date of 10/10/2016 and case code 6405.
24-oz./1.5-lb. cartons of “SIGNATURE Pick 5 CORNDOGS – 8 Honey Batter Dipped Franks On A Stick” with a “Use By” date of 4/6/2017 and case code 6071.
42.72-oz./2.67-lb. cartons of “BAR-S CLASSIC CORN DOGS – 16 Honey Batter Dipped Franks On A Stick” with “Use By” dates of 4/7/2017 and 4/8/2017 and case code 6396.
48-oz./3-lb. cartons of “BAR-S CLASSIC CORN DOGS – 16 Honey Batter Dipped Franks On A Stick” with package code 14054, “Use By” dates of 4/6/2017 and 4/9/2017, and case code 14038.
The products subject to recall bear establishment number “EST. P-81A” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.
Bar-S Foods notified FSIS’ Dallas District Office on July 19, 2016, of its intention to recall five chicken and pork hot dog and corn dog products that could potentially be contaminated with Listeria monocytogenes. The firm has not received test results for Listeria monocytogenes in connection with the recalled products, but due to recurring Listeria species issues at the firm, it has decided to remove the products from commerce as a precautionary measure. There have been no confirmed reports of illnesses or adverse reactions due to consumption of these products.
Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
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.
Members of the media with questions regarding the recall can contact Manuel Rivera, Bar-S Foods’ Vice President of Marketing, at 1-888-241-6102. Consumers with questions regarding the recall can call the Bar-S Foods Consumer Hotline at 1-888-965-6134.
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.
Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue
For Immediate Release
August 15, 2016
Contact
Consumers
Cook Medical Customer Relations
CustomerRelationsNA@cookmedical.com
1-800-457-4500 or 1-812-339-2235
Media
Marsha Lovejoy, Global Manager,
Corporate Content Strategy
marsha.lovejoy@cookmedical.com
1-812-339-2235 ext. 2750
Announcement
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled wire guide units.
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date.
The Roadrunner UniGlide Hydrophilic Wire Guide is intended for use in the delivery of percutaneous catheters into the peripheral vasculature.
A full list of affected products and lot numbers is attached. Products can be identified by the part number and lot number on the outer label of the package. Products in this recall were distributed globally.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all recalled units and return the affected products to Cook as soon as possible for credit.
The FDA and other regulatory agencies around the world have been notified of this action.
Consumers with medical questions or concerns should contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time. For information regarding the recall, please contact Stericycle Expert Solutions at 1-866-912-9552.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.
Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at CustomerRelationsNA@cookmedical.com.
RPN
GPN
Affected Lot Numbers
HPW-35-150
G56149
6911533, 6911535, 6935851, 6968779, 6981351, 6986897, 6986898, 7000733
HPW-35-180
G56150
6981026, 6981346
HPWA-18-180
G56160
7000727, 7000730, 7000735, NS6999761
HPWA-18-260
G30489
6935843, 6935846, 6948858, 6965469, 6981347, NS6948859
HPWA-18-320
G30490
6911545, 6981349, 7015899
HPWA-25-260
G30491
7015857, 7019022, 7019027
HPWA-35-150
G56173
6911529, 6911530, 6948854, 6948855, 6948855X, 6948856, 6955232, 6955233, 6955234, 6955234X,
6955235, 6961754, 6961756, 6961757, 6961758, 6965625, 6965626, 6968777, 6975365, 6981022,
6995077, 6995078, 6995080, 7012528, 7012529, NS6975369, NS6981025, NS6995079, NS7000728
HPWA-35-180
G56174
6911522, 6911523, 6911524, 6911526, 6911527, 6911528, 6935844, 6955228, 6955229, 6955230,
6955231, 6965235, 6965236, 6965237, 6965238, 6975367, 6975368, 6988487, 6988488, 7015853,
7015854, 7016252, 7016253, 7019017, 7019018, 7019491, 7019492, 7019493, 7019494, 7021223,
7021225, 7021226, 7021227, NS6911520, NS6935845, NS6935847, NS7019495
HPWA-35-260
G30492
6948857, 6961759, 6965240, 6986896, 7000724, 7000725, 7000726, 7012840, 7019019, 7019020, NS6965239, NS6968778, NS6999757, NS6999758, NS7012841, NS7019023, NS7019024
HPWA-35-80
G56172
6948860
HPWAS-35-150
G56176
6919676, 6919680, 6935853, 6935855, 6961761, 6995082, 6995083, 7022591, NS6935854
HPWAS-35-180
G56177
6961752, 6961753, 7012526, 7012527, 7015855, 7015856, 7021222, 7021224
HPWAS-35-260
G30506
6911549, 6911551, 6911552, 6919678, 6935848, 6935849, 6935850, 6935852, 6948861, 6948862,
6955236, 6955237, 6997860, 7000732, 7015897, 7015898, 7019025
HPWS-35-150
G56152
6961755, 6961760, 6999760
HPWS-35-180
G56153
6992197, 6992198, 6999759, 7012530
John
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Researchers examine how Parkinson’s disease alters brain activity over time
Tracking neural changes could help researchers test therapies that slow disease progression.
Neuroscientists peered into the brains of patients with Parkinson’s disease and two similar conditions to see how their neural responses changed over time. The study, funded by the NIH’s Parkinson’s Disease Biomarkers Program and published in Neurology, may provide a new tool for testing experimental medications aimed at alleviating symptoms and slowing the rate at which the diseases damage the brain.
“If you know that in Parkinson’s disease the activity in a specific brain region is decreasing over the course of a year, it opens the door to evaluating a therapeutic to see if it can slow that reduction,” said senior author David Vaillancourt, Ph.D., a professor in the University of Florida’s Department of Applied Physiology and Kinesiology. “It provides a marker for evaluating how treatments alter the chronic changes in brain physiology caused by Parkinson’s.”
Parkinson’s disease is a neurodegenerative disorder that destroys neurons in the brain that are essential for controlling movement. While many medications exist that lessen the consequences of this neuronal loss, none can prevent the destruction of those cells. Clinical trials for Parkinson’s disease have long relied on observing whether a therapy improves patients’ symptoms, but such studies reveal little about how the treatment affects the underlying progressive neurodegeneration. As a result, while there are treatments that improve symptoms, they become less effective as the neurodegeneration advances. The new study could remedy this issue by providing researchers with measurable targets, called biomarkers, to assess whether a drug slows or even stops the progression of the disease in the brain.
“For decades, the field has been searching for an effective biomarker for Parkinson’s disease,” said Debra Babcock, M.D., Ph.D., program director at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “This study is an example of how brain imaging biomarkers can be used to monitor the progression of Parkinson’s disease and other neurological disorders.”
“The Parkinson’s Disease Biomarkers Program is an essential part of moving towards the development of treatments that impact the causes, and not just the symptoms, of Parkinson’s disease,” added NINDS program director Katrina Gwinn, M.D.
Dr. Vaillancourt’s team used functional magnetic resonance imaging (fMRI) to measure activity in a set of pre-determined brain areas in healthy controls, individuals with Parkinson’s disease, and patients with two forms of “atypical Parkinsonism” – multiple systems atrophy (MSA) and progressive supranuclear palsy (PSP) – that have symptoms similar to those of Parkinson’s disease. The researchers selected the specific brain regions, which are critical for movement and balance, based on the findings of past studies in people with these three conditions. The participants each underwent two scans spaced a year apart, during which they completed a test that gauged their grip strength.
The healthy controls showed no changes in neural activity after a year, whereas the participants with Parkinson’s showed reductions in the response of two brain regions called the putamen and the primary motor cortex. Previous research had shown reduced activity in the primary motor cortex of Parkinson’s patients, but the new study is the first to suggest that this deficit worsens over time. Activity decreased in MSA patients in the primary motor cortex, the supplementary motor area, and the superior cerebellum, while the individuals with PSP showed a decline in the response of these three areas and the putamen.
Dr. Vaillancourt’s team now hopes to use its newly discovered biomarkers, in addition to one it had previously identified, to test whether an experimental medication known to improve Parkinson’s symptoms also slows the progression of those brain changes.
“These markers allow us to evaluate disease-modifying therapeutics because we know that the control group doesn’t change over a year but patient groups do,” Dr. Vaillancourt explained. “We can see whether a therapeutic prevents that change from occurring, and if it does, then that suggests it might have a disease-modifying effect.”
The study was supported by the NIH (NS052318, NS075012, NS082168).
The NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®
Reference
Burciu et al. Functional MRI of Disease Progression in Parkinson’s Disease and Atypical Parkinsonian Syndromes. Neurology. July 15, 2016. DOI: 10.1212/WNL.0000000000002985.
John
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BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS® easyMAG® Magnetic Silica for Nucleic Acid Extraction
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
Recalled Product:
NucliSENS® easyMAG® Magnetic Silica (Reference Number: 280133)
Lot Numbers: Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017FA1MS, Z017KG1MS, Z017KH1MS
Devices Recalled in the U.S.: 1892 nationwide
Device Use
The NucliSENS® easyMAG® Magnetic Silica (MagSIL) is used to extract nucleic acids (RNA or DNA) from biological samples, such as blood, tissue, etc., which could then be used in various applications for molecular infectious disease assays, molecular oncology assays, and molecular genetics assays.
Reason for Recall
BioMerieux is recalling the NucliSENS® easyMAG® Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance with certain downstream applications. The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Who May be Affected
Laboratories who utilize the NucliSENS® easyMAG® nucleic acid extraction system as part of diagnostic applications.
Health care providers who utilize laboratories who use the NucliSENS® easyMAG® nucleic acid extraction system as part of diagnostic applications.
All patient groups receiving a diagnosis using laboratories that utilize the NucliSENS® easyMAG nucleic acid extraction system as part of diagnostic applications.
What to Do
On July 18, 2016 and on August 10, 2016, bioMerieux sent Urgent Product Safety Correction Notices to affected customers. Please follow the company’s second correction notice dated August 10, 2016 for detailed instructions. The notice asked customers to:
Reduce the sample input volume to 200μl
Note: If using bioMerieux downstream applications (PCR/RT-PCR ARGENE) and NucliSENS easyQ HIV 1 v2.0 (NASBA technology), the sample input should be in accordance with the intended for use (IFU) claims for the assay and should be no greater than 400μl.
The laboratory must verify that the expected performance is not affected by the extraction reagents.
Use an internal extraction control which mimics the target sample (with same nature/structure/volume/matrix) or is designed to detect decreased assay performance (including the extraction process), and/or external controls as recommended in the instructions for use and as required by US regulation to detect any extraction performance issue.
Do not use for single-stranded RNA virus applications if the RNA is extracted without a matrix (i.e. in water).
Please review all results that were generated with the affected lots of extraction reagent to determine the appropriate course of action.
If you observe any issues with extraction or assay performance, contact your local customer service representative.
Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product.
Contact Information:
Customers with questions may contact bioMerieux Clinical Customer Service at (800) 682-2666 or bioMerieux Industry Customer Service at (800) 634-7656.
Date Recall Initiated:
July 18, 2016
How do I report a Problem?
Consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
Full List of Distribution Dates:
Lot Number
Distribution Start Date
Distribution End Date
Z017BB1MS
01/14/2016
01/28/2016
Z017BF1MS
01/04/2016
05/09/2016
Z017CA1MS
02/17/2016
05/09/2016
Z017BE1MS
12/21/2015
12/21/2015
Z017CC1MS
02/08/2016
04/21/2016
Z017CD1MS
03/08/2016
04/28/2016
Z017CH1MS
04/05/2016
04/18/2016
Z017BD1MS
12/21/2015
01/08/2016
Z017DB1MS
02/23/2016
04/05/2016
Z017BA1MS
10/27/2015
01/04/2016
Z017CF1MS
03/23/2016
04/12/2016
Z017CE1MS
03/16/2016
04/01/2016
Z017CG1MS
02/23/2016
04/01/2016
Z017DA1MS
04/14/2016
05/02/2016
Z017DC1MS
04/26/2016
05/24/2016
Z017DD1MS
05/11/2016
Ongoing
Z017EA1MS
04/26/2016
Ongoing
Z017EB1MS
06/17/2016
Ongoing
Z017FB1MS
04/12/2016
04/18/2016
Z017KF1MS
05/09/2016
06/08/2016
Z017KG1MS
05/09/2016
Ongoing
Z017KH1MS
06/03/2016
Ongoing
John
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The MedWatch July 2016 Safety Labeling Changes posting includes 52 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm514705.htm
Avelox (moxifloxacin hydrochloride)
Acetadote (acetylcysteine) Injection
Alinia (nitazoxanide)
Aromasin (exemestane)
Asmanex HFA (mometasone furoate)
Caprelsa (vandetanib)
Cipro (ciprofloxacin hydrochloride) Tablets, Solution, Oral Suspension
Cipro XR (ciprofloxacin extended release) Tablets
Clinolipid (lipid injectable emulsion)
Dexilant (dexlansoprazole delayed-release capsules)
Dulera (formoterol fumarate, mometasone furoate)
Dysport (abobotulinumtoxinA)
Effient (prasugrel)
Eliquis (apixaban)
Epivir (lamivudine) Tablets and Oral Solution
Evotaz (atazanavir/cobicistat)
Factive (gemifloxacin mesylate)
Faslodex (fulvestrant)
Flovent Diskus (fluticasone propionate inhalation powder)
Flovent HFA (fluticasone propionate)
Glyxambi (empagliflozin and linagliptin)
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)
Humulin R U-500 (insulin human injection)
Ilaris (canakinumab)
Isoniazid Tablets
Jardiance (empagliflozin)
Kadcyla (ado-trastuzumab emtansine)
Kepivance (palifermin) Injection
Lamprene (clofazimine)
Levaquin (levofloxacin)
Mirapex (pramipexole)
Mirapex ER (pramipexole) extended-release
Mirvaso (brimonidine)
Moxifloxacin Injection
Namzaric (memantine and donepezil hydrochlorides) Extended-release
Noroxin (norfloxacin)
Plegridy (peginterferon beta-1a)
Pravachol (pravastatin sodium)
Prismasol and Phoxillum Renal Replacement Solution
Synjardy (empagliflozin and metformin hydrochloride)
Tarka (trandolapril/verapamil hydrochloride ER tablets)
Thallous Chloride T1201 Injection
Xolair (omalizumab) Lyophilized Powder
Yondelis (trabectedin)
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.
Oriental Packing Co., Inc. Issues Alert on Lead in Curry Powder
For Immediate Release
August 12, 2016
Contact
Consumers
Oriental Packing Company
800-809-9793
Announcement
Oriental Packing Co., Inc., Miami, Florida is recalling approximately 377,000 lbs. of the following blended seasoning curry products because it is contaminated with lead. Lead can accumulate in the body over time and can cause serious and sometimes permanent adverse health consequences.
Blue Mountain Brand
Blue Mountain Country Mild Curry Powder
Blue Mountain Country Hot Curry Powder
Blue Mountain Country Hot Jamaican Jerk Curry Seasoning
Jamaica Choice Brand
Jamaica Choice Mild
Jamaica Hot Curry Powder
Ocho Rios Brand
Ocho-Rios Jamaican Nice Mild Curry Powder
Ocho Rios Spicy Curry Powder
Ocho Rios Jerk Curry Seasoning Mild
Ocho Rios Jerk Curry Seasoning Spicy
Oriental Brand
Oriental Mild Curry Powder
Oriental Hot Curry Powder
Grace Brand
Grace Mild Curry Powder
Grace Hot Curry Powder
Grace Caribbean Curry Powder
Grace Caribbean Tradition Hot Curry Powder
Product was distributed in New York and Florida and was sold through internet sales and retail stores nationwide.
No illnesses have been reported to date.
The products can be identified by the label bearing the above names in glass and plastic bottles. The sizes including 2oz, 4oz, 6oz, 8oz, 22oz and 5 lb. Product can be identified by the lot numbers and best before date listed below. This information can be found on the top of the cap or at the bottom of the bottle.
HOT/SPICY LOT NUMBERS BEST BEFORE DATE: 11/1/18 through 6/29/19
12516
21616
31616
40216
42116
51816
60316
62416
111915
12616
21716
31916
40816
42216
51916
61316
62716
12716
22216
32319
41216
42716
52316
61416
62916
12916
30116
32416
41316
42816
53116
61516
120115
20316
30516
32516
41416
42916
60116
61616
120215
20916
30716
32616
42016
51716
60216
62316
120315
MILD LOT NUMBERS BEST BEFORE DATE: 11/1/18 through 6/29/19
12516
20316
21716
31516
40216
41916
51516
60716
62716
12616
20416
22216
31816
40316
41416
51616
61316
62816
12716
20516
22616
31916
40416
42016
52716
61416
120316
12816
20816
30216
32216
40516
42116
53116
61516
120315
13016
20916
30516
32416
40716
42216
60216
61616
112015
20116
21216
30716
32516
41216
42516
60316
62216
112315
20216
21316
31416
32916
41316
50316
60616
62316
HOT/SPICY JERK LOT NUMBER BEST BEFORE DATE: 11/1/18 through 6/29/19
013016
MILD HEAT JERK LOT NUMBER BEST BEFORE DATE: 11/1/18 through 6/29/19
041416
The recall was the result of a routine sampling program by the New York State Health Department, which revealed that the finished products contained lead. Oriental Packing Co., Inc. has ceased the production and distribution of the product as FDA and the company continues their investigation as to what caused the problem.
No illnesses have been reported to date.
Consumers are urged to dispose unused product following EPA and/or state and county regulations or return it to the place of purchase for a full refund. Consumers with questions may contact Oriental Packing Company Monday through Friday between the hours of 8:00 a.m. to 5:00 p.m. EST at this toll free number 800-809-9793.
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.
Ton Shen Health Recalls “DHZC-2 Tablet” Because of Possible Health Risk
For Immediate Release
August 11, 2016
Contact
Consumers
Ton Shen Health
1-312-842-2775
Announcement
View Product Photos
Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time.
The recalled "DHZC-2" tablets were mostly sold locally in Chicago area in retails stores and some were distributed to other states through mail orders.
The product comes in a 1.6 ounce, white plastic package marked with lot # 2163-844 on the bottom. UPC: 616042102727
One illness has been reported to date in connection with this problem.
The potential for contamination was noted after FDA notice of higher level of lead presence in DHZC-2 samples.
The sale of the product has been suspended and inventory put on hold while FDA and the company continue to investigate the source of the problem.
Consumers who have purchased DHZC-2 tablets are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-312-842-2775 central standard time, Monday to Friday, from 9:30AM to 5:00PM.
John
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FDA Issues Final Rule on Food Ingredients that May Be "Generally Recognized as Safe"
Constituent Update
August 12, 2016
In a step to strengthen its oversight of food ingredients, the U.S. Food and Drug Administration today issued a final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS). Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives.
The rule addresses the types of scientific evidence that can be used to demonstrate safety as well as the role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted.” The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts. The final rule also formalizes the voluntary GRAS notification procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010.
The FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with today’s rule. While the FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts.
The GRAS final rule is the most recent step we are taking to strengthen the FDA’s oversight of substances added to human and animal food. Next steps include issuing additional guidances related to the GRAS regulations. As part of the Foods and Veterinary Medicine Program’s Strategic Plan, the FDA will develop and implement innovative regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances.
For more information:
Final Rule: Substances Generally Recognized as Safe Rule
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.
Rabbit Creek Products recalls certain flavors of bread, muffin and brownie mixes because of a possible health risk
For Immediate Release
August 11, 2016
Contact
Consumers
Rabbit Creek Products
1-800-837-3073
Announcement
Rabbit Creek Products of Louisburg, KS is recalling certain flavors of Bread mixes, Muffin mixes and Brownie mixes under the Rabbit Creek Products and other Private label brand names due to the potential presence of Escherichia coli O121 (E. coli O121). People usually get sick from E. coli O121, also referred to as STEC O121, 2-8 days (average of 3-4 days) after swallowing the bacteria. Most people develop diarrhea (often bloody) and abdominal cramps. Most people recover within a week. Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS). HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems. Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination. People who experience these symptoms should seek emergency medical care immediately.
The recalled dry mixes were distributed nationwide in retail stores and online sales December 2015 through February 2016. Please see the list below for the mixes involved and the best by dates for those affected mixes. For representative labeling, please see our website, www.rabbitcreekgourmet.com
No illnesses have been reported to date to Rabbit Creek. No other products sold by Rabbit Creek Products are involved in this recall
This recall was initiated after our suppliers notified us that we received General Mills flour which was recalled due to the potential presence of E. coli O121.
Please destroy any affected product and return the label to Rabbit Creek, PO Box 1059, Louisburg, KS 66053 for a refund. Consumers with questions may contact the company at 1-800-837-3073 Monday through Thursday between 8am and 4pm CT.
Bread List
http://www.fda.gov/Safety/Recalls/ucm516340.htm
Brownie List
http://www.fda.gov/Safety/Recalls/ucm516339.htm
Muffin List
http://www.fda.gov/Safety/Recalls/ucm516341.htm
John
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http://www.cpsc.gov/en/Recalls/2016/SpeeCo-Recalls-Fence-Wire-Stretchers/
SpeeCo Recalls Fence Wire Stretchers Due to Laceration Hazard
Recall date: AUGUST 11, 2016
Recall number: 16-244
Recall Summary
Name of product: Fence wire stretchers
Hazard: A recoiling wire can be released from the stretcher unexpectedly and strike bystanders, posing a laceration hazard.
Consumer Contact:
SpeeCo toll-free at 855-271-7189 from 8 a.m. to 5:30 p.m. CT Monday through Friday or online at www.speeco.com and click on Recalls for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 60,000 (in addition, 1,800 were sold in Canada)
Description
This recall involves SpeeCo’s fence wire stretchers, with or without a ratchet control, used for gripping and tightening any type of wire. The black stretcher has a rubber grip on the lever handle. It measures about 12 inches high, 1 inch wide and 32 inches long. SpeeCo and model S16111500, S161115TSC or S16112000 is printed on a label on the product packaging.
Incidents/Injuries
The firm has received two reports of a recoiling wire releasing from the stretcher unexpectedly, which caused cuts, abrasions and scratches to the user.
Remedy
Consumers should immediately stop using the recalled fence wire stretchers and contact SpeeCo to receive a full refund.
Sold at
Ace and True Value hardware stores and other supply and farm ranch stores nationwide and online at Amazon.com from April 2015 through August 2016 from about $40.
Importer(s)
SpeeCo Inc., of Golden, Colo.
Manufactured in
China
John
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News Release
Sam Kane Beef Processors, LLC Recalls Ground Beef Products Due To Possible Foreign Material Contamination
Class II Recall
071-2016
Health Risk: Low
Aug 10, 2016
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
WASHINGTON, Aug. 10, 2016 – Sam Kane Beef Processors, LLC, a Corpus Christi, Texas establishment, is recalling approximately 60,350 pounds of ground beef products that may be contaminated with foreign materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The ground beef packages were produced on July 26, 2016. The following products are subject to recall: View Labels PDF Only
10-lb. (4.54 kg) chubs containing “Hill Country Fare Ground Beef” 73% Lean/27% Fat with a Packed On date of 7/26/2016, a Use-By date of 8/15/2016, and bearing case code number 00090180.
5-lb. (2.27 kg) chubs containing “Hill Country Fare Ground Beef” 73% Lean/27% Fat with a Packed On date of 7/26/2016, a Use-By date of 8/15/2016, and bearing case code number 00090150.
3-lb. (1.37 kg) chubs containing “Hill Country Fare Ground Beef” 73% Lean/27% Fat with a Packed On date of 7/26/2016, a Use-By date of 8/15/2016, and bearing case code number 00090170.
The products subject to recall bear establishment number “EST. 337” inside the USDA mark of inspection or on the product packaging seam. These items were shipped to three HEB Grocery distribution centers in Texas.
The problem was discovered when the establishment was notified of a consumer’s complaint of a small piece of metal in their purchased 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 Mysti Richardson, Director of Marketing, at (361) 241-5000, ext. 241. Media with questions about the recall can contact David Mooney, President of Sales, at (361) 241-5000, ext. 314.
John
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http://www.cpsc.gov/en/Recalls/2016/Shocker-Paintball-Recalls-Paintball-Markers/
Shocker Paintball Recalls Paintball Markers Due to Risk of Injury
Recall date: AUGUST 10, 2016
Recall number: 16-243
Recall Summary
Name of product: Shocker RSX paintball markers/guns
Hazard: The chamber part assembly can unexpectedly eject from the rear of the marker, posing a risk of impact injury to the user.
Consumer Contact:
Shocker Paintball toll-free at 866-253-2338 from 9 a.m. to 5 p.m. ET Monday through Friday, or online at http.Recall.ShockerPaintball.com. Consumers can also visit the firm’s website at www.shockerpaintball.com and click on “Important Recall” link directly below the menu bar for more information.
Recall Details
Units
About 5,200
Description
This recall involves Shocker RSX paintball markers equipped with a blue main chamber. The Shocker RSX is an electropneumatic paintball marker which utilizes compressed air to fire .68 caliber gelatin encapsulated paintballs. The markers are 8.5 inches tall by 8 inches long (without the barrel). Markers included in this recall have a blue main chamber. The blue main chamber has three large rectangular cut-outs on the main body and a ring of seven small perpendicular holes in the neck of the chamber. All Shocker RSX markers are subject to this recall. HK Army Paintball markers included in the recall were sold in the following color combinations:
Base Color
Accent Color
Main Chamber
Black
Red
Blue
Pewter
Blue
Blue
Red
Pewter
Blue
White
Black
Blue
Black
Gold
Blue
Purple
Green
Blue
Incidents/Injuries
The firm has received eight reports of main chamber failures. In all cases the chamber assembly was ejected out the rear of the gun with force. No injuries have been reported.
Remedy
Consumers should immediately stop using the recalled marker and properly dispose of the blue chamber. Consumers can contact Shocker Paintball for a free replacement high-flow chamber or an authorized dealer to have the free replacement high-flow chamber installed at no charge.
Sold at
Paintball dealers and distributors nationwide and online at ShockerPaintball.com from May 2015 to August 2016 for between $800 and $1,000.
Importer(s)
Shocker Paintball, of Loyalhanna, Pa.
Distributor(s)
Shocker Paintball, of Loyalhanna, Pa.
Manufactured in
Taiwan
John
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http://www.cpsc.gov/en/Recalls/2016/Dennis-East-International-Recalls-Whiskey-Glass-and-Stone-Sets/
Dennis East International Recalls Whiskey Glass and Stone Sets Due to Laceration Hazard
Recall date: AUGUST 10, 2016
Recall number: 16-242
Recall Summary
Name of product: Whiskey Glass and Stone Sets
Hazard: The whiskey glass can spontaneously break during use, posing a laceration risk to consumers.
Consumer Contact:
Dennis East International at 800-430-5665 from 8 a.m. to 6 p.m. ET Monday through Friday or online at www.deidirect.com. Click on Product Recall Notice at top of page for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 1,200 (in addition, about 8 units were sold in Canada)
Description
This recall involves Dennis East International Whiskey Glass and Stone Sets. The sets include a 16 once clear glass, four grey chilling stones and a black cloth bag. The SKU number is SKU 30335.
Incidents/Injuries
The firm has received two reports of the whiskey glass breaking. No injuries have been reported.
Remedy
Consumers should immediately stop using the recalled glasses and contact the firm for a full refund.
Sold at
Providence Creations, Javic Wholesale, Woot stores and online at Woot.com from May 2015 through July 2016 for about $20.
Distributor(s)
Dennis East International, LLC of Yarmouth Port, Mass.
Manufactured in
China
John
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News Release
Al Shabrawy Incorporated Recalls Meat and Poultry Products Due To Misbranding and Undeclared Allergens
Class I Recall
070-2016 EXP
Health Risk: High
Aug 10, 2016
Congressional and Public Affairs
Benjamin A. Bell
(202) 720-9113
EDITORS NOTE: This release is being reissued as an expansion of the August 6, 2016 recall to include additional products. The first recall 070-2016 on August 6, 2016, recalled an undetermined amount of basterma, sausage, soujouk, salami, mortadella, makanek, and bologna products due to misbranding and undeclared allergens. The expansion of the recall is based on evidence provided by FSIS that all package sizes and brands of the products produced during the initial recall dates of January 1, 2015 to August 4, 2016 are misbranded as described in the initial recall.
WASHINGTON, Aug. 10, 2016 – Al Shabrawy Meat Inc., a South River, N.J. establishment, is recalling an undetermined amount of meat and poultry products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Some of the products contain pistachio nut and soy, known allergens, which are not declared on the product label.
The basterma, sausage, soujouk, salami, mortadella, makanek, bologna, Lahmajun (meat pie) and other sausage-like items were produced on various dates between Jan. 1, 2015 and Aug. 4, 2016. The following products are subject to recall:
View Labels PDF Only
“TAZAH, SULTAN, & YORUK SLICED BASTERMA” – cryovaced and weighed at the time of sale
“AL MARAAI, AL HALU, BAROODY, & AL SHABRAWY SLICED AND WHOLE BASTERMA” – cryovaced and weighed at the time of sale
“AL SHABRAWY, TAZAH, & BAROODY MAKANEK” – cryovaced and weighed at the time of sale
“TAZAH EGYPTIAN STYLE FRESH SAUSAGE” – cryovaced and weighed at the time of sale
“AL SHABRAWY FRESH SAUSAGE” – cryovaced and weighed at the time of sale
“BAROODY & SULTAN DRIED SOUJOUK” – cryovaced and weighed at the time of sale
“SEVAN LAHMAJUN” – cryovaced and weighed at the time of sale
1-lb. plastic tubes (chubs) of “AL SHABRAWY PLAIN, OLIVE, & BLACK PEPPER SALAMI”
5-lb. plastic tubes (chubs) of “AL SHABRAWY PLAIN, OLIVE, & BLACK PEPPER SALAMI”
1-lb. plastic tubes (chubs) of “AL SHABRAWY OLIVE & PISTACHIO MORTADELLA”
5-lb. plastic tubes (chubs) of “AL SHABRAWY OLIVE & PISTACHIO MORTADELLA”
The products subject to recall bear establishment number “EST. 19160” inside the USDA mark of inspection. These items were shipped to retail locations and wholesalers in California, Florida, Illinois, New Jersey, New York and Pennsylvania.
The problem was discovered during an on-going FSIS investigation at the establishment following a complaint to the agency. The major public health concerns include listing hydrolyzed plant protein in the ingredient statement of the beef bologna and beef mortadella, but not specifying that soy, an allergen, is the source of that protein. Also, the beef mortadella products did not declare pistachio nut, an allergen, on individual package ingredient statements, although some cases of the product display a sticker stating “Pistachio” was in the product. FSIS also found that beef salami and beef bologna products contained poultry ingredients and a sausage product tested positive for Red Dye #40, which is not declared on product labels. Additionally, raw beef trim, designated for cooking only, was used in raw non-intact finished products.
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.
Details of the first recall are: WASHINGTON, Aug. 6, 2016 – Al Shabrawy Meat Inc., a South River, N.J. establishment, is recalling an undetermined amount of meat and poultry products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Some of the products contain pistachio nut and soy, known allergens, which are not declared on the product label.
The beef bologna, beef salami, mortadella and other sausage-like items were produced on various dates between Jan. 1, 2015 and Aug. 4, 2016. The following products are subject to recall:
1-lb. plastic container of “AL SHABRAWY COOKED BEEF SALAMI” with UPC code 4203601235 printed on the label.
16-oz. rolls of “AL SHABRAWY COOKED BEEF BOLOGNA” with UPC code 4203601237 printed on the label.
5-lb. rolls of “AL SHABRAWY COOKED BEEF BOLOGNA” with UPC code 4203601236 printed on the label.
1-lb. plastic container of “AL SHABRAWY COOKED BEEF MORTADELLA” with UPC code 4203601236 printed on the label.
5-lb. plastic container of “AL SHABRAWY COOKED BEEF SALAMI PLAIN” with UPC code 4203601235 printed on the label.
20-lb. cases, containing five pieces of “AL SHABRAWY BASTERMA” with UPC code 4203601231 printed on the label.
1-lb. plastic container of “BAROODY COOKED BEEF SALAMI” with UPC code 4203601235 printed on the label.
1-lb. plastic container of “BAROODY MAKANEK (Raw)” with UPC code 4203601223 printed on the label.
75-lb. plastic container of “BAROODY SOUJOUK (Dried Beef Sausage)” with UPC code 4203601222 printed on the label.
The products subject to recall bear establishment number “EST. 19160” inside the USDA mark of inspection. These items were shipped to retail locations and wholesalers in California, Florida, Illinois, New Jersey, New York and Pennsylvania.
The problem was discovered during an on-going FSIS investigation at the establishment following a complaint to the agency. The major public health concerns include listing hydrolyzed plant protein in the ingredient statement of the beef bologna and beef mortadella, but not specifying that soy, an allergen, is the source of that protein. Also, the beef mortadella products did not declare pistachio nut, an allergen, on individual package ingredient statements, although some cases of the product display a sticker stating “Pistachio” was in the product. FSIS also found that beef salami and beef bologna products contained poultry ingredients and a sausage product tested positive for Red Dye #40, which is not declared on product labels. Additionally, raw beef trim, designated for cooking only, was used in raw non-intact finished products.
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 and the company are concerned that some product may be frozen and in consumers' freezers.
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 Medhat Mechaeil, company owner, at (732) 238-0428.
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.
Country Home Voluntarily Recalls 12- and 24-Count Gourmet Cookies Sold Through ShopRite Stores Fresh Bake Department
For Immediate Release
August 5, 2016
Contact
Consumers
ShopRite
ShopRite.com
1-800-ShopRite (1-800-746-7748)
Media
Karen O'Shea
karen.o'shea@wakefern.com
(732) 906-5932
Announcement
Country Home has initiated a voluntary recall of Gourmet Chocolate Chunk Salted Caramel Cookies sold at ShopRite stores in its Fresh Bake department. These cookies were sold in 12- and 24-count containers and may also be part of the 12- and 24-count variety packages of cookies.
The recalled cookies may contain small pieces of metal fragments. This is an isolated incident and no other products sold in the Fresh Bake department are involved in this product recall.
The cookies were sold between July 19 and Aug. 4, 2016. Affected items have the following information noted on their labels: Name: Gourmet Chocolate Chunk Salted Caramel Cookies, UPC 28978500000, UPC 28977600000; Gourmet Variety Pack Cookies, UPC 38978600000 and UPC 28977200000 and are sold in ShopRite Fresh Bake departments.
"We are advising customers who purchased 12- and 24-count Gourmet Chocolate Chunk Salted Caramel Cookies and Gourmet Variety Pack Cookies at ShopRite between July 19 and Aug. 4 to return them for an immediate refund or replacement," said ShopRite spokeswoman Karen Meleta.
No injuries related to the recall have been reported.
ShopRite has reached out via phone calls and email to ShopRite Price Plus Club customers who have purchased this product to alert them to the recall. ShopRite urges its customers to keep their Price Plus Club information updated, so they can be contacted in case of such events. Customers wishing to update their information can call 1-800-SHOPRITE or visit ShopRite.com.
Customer questions or concerns about the recall can be directed to 1-800-ShopRite (1-800-746-7748).
About ShopRite
ShopRite is the registered trademark of Wakefern Food Corp., a retailer-owned cooperative based in Keasbey, NJ, and the largest supermarket cooperative in the United States. With more than 260 ShopRite supermarkets located throughout New Jersey, New York, Pennsylvania, Connecticut, Delaware and Maryland, ShopRite serves more than six million customers each week. A long-time supporter of key community efforts, ShopRite is dedicated to fighting hunger in the communities it serves. Through its ShopRite Partners In Caring program, ShopRite has donated $40 million to 1,700 worthy charities and food banks since the program began in 1999. As a title sponsor of the LPGA's ShopRite Classic, ShopRite has raised more than $28 million for local organizations, hospitals and community groups. For more information, please visit www.ShopRite.com.
John
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http://www.niaid.nih.gov/news/newsreleases/2016/Pages/peanut-OIT.aspx
For Immediate Release: Wednesday, Aug. 10, 2016
MEDIA AVAILABILITY
Oral Immunotherapy Is Safe, Effective Treatment for Peanut-Allergic Preschoolers, Study Suggests
WHAT:
Nearly 80 percent of peanut-allergic preschool children successfully incorporated peanut-containing foods into their diets after receiving peanut oral immunotherapy (OIT), a clinical trial has found. Peanut OIT involves eating small, gradually increasing amounts of peanut protein daily. Low-dose and high-dose OIT were safe and equally effective at suppressing allergic immune responses to peanut, investigators found. The work was partly supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health.
Previous studies with older children showed that peanut OIT can offer some protection against potentially life-threatening anaphylaxis caused by peanut exposure. In this study, researchers led by Wesley Burks, M.D., of the University of North Carolina at Chapel Hill, assessed whether giving OIT to younger children whose duration of peanut allergy was short could alter the course of the allergy and allow safe introduction of peanut into the diet.
The study team enrolled 40 peanut-allergic children aged 9 to 36 months. They randomly assigned participants to either high-dose peanut OIT with a target daily dose of 3,000 milligrams peanut protein or a low-dose regimen with a target dose of 300 milligrams. Nearly all participants experienced some side effects, such as abdominal pain, but these were generally mild, and required little or no treatment. After receiving OIT for 29 months on average, participants avoided peanut completely for four weeks before attempting to reintroduce it into their diets.
Almost 80 percent of participants successfully reintroduced peanut with no allergic response, with no significant differences between the low-dose and high-dose arms. Comparison of the OIT-treated children with a control group of 154 peanut-allergic children who had avoided peanut showed that OIT-treated children were 19 times more likely to successfully incorporate peanut into their diets. The investigators are continuing to monitor the OIT-treated participants to assess the long-term treatment outcomes.
Currently, the NIAID-supported Immune Tolerance Network is conducting a randomized trial called IMPACT to determine whether peanut OIT can lower the risk of allergic reactions, induce tolerance and change the immune responses of peanut-allergic children aged 12 to 48 months.
ARTICLE:
BP Vickery et al. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. Journal of Allergy and Clinical Immunology DOI: 10.1016/j.jaci.2016.05.027 (2016).
WHO:
Marshall Plaut, M.D., chief of the Food Allergy, Atopic Dermatitis and Allergic Mechanisms Section in NIAID’s Division of Allergy, Immunology and Transplantation, is available to discuss the findings.
CONTACT:
To schedule interviews, please contact Hillary Hoffman, (301) 402-1663, niaidnews@niaid.nih.gov.
John
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Public Notification: Citrus’ Fit contains hidden drug ingredients
[8-9-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Citrus’ Fit, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Citrus’ Fit contains sibutramine and desmethylsibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Desmethylsibutramine is a substance structurally similar to sibutramine. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
John
Recall: Croissants
in Pinching Pennies
Posted
http://www.fda.gov/Safety/Recalls/ucm517124.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.
Bakers of Paris Recalls Croissants Sold at Whole Foods Market® Stores in Northern California Due to Undeclared Allergen
For Immediate Release
August 16, 2016
Contact
Consumers
Bakers of Paris
customer-service@bakersofparis.com
415-468-9100, ext. 221
Media
Lionel Robbe-Jedeau
lionel@bakersofparis.com
http://www.fda.gov/Safety/Recalls/ucm517124.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos
415-468-9100
Announcement
View Product Photos
http://www.fda.gov/Safety/Recalls/ucm517124.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos
Bakers of Paris (Brisbane California), is recalling plain and chocolate croissants sold in 18 Northern California Whole Foods Market stores due to an undeclared allergen. The croissants, sold individually in self-service cases and in clear plastic packs of four, are made with an egg wash which is not declared on the ingredient list. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening reactions if they consume this product.
One allergic reaction has been reported to date.
Affected products in the self-service case were labeled “Croissant” or “Chocolate Croissant.” Both carry a PLU of 481976. Details for packaged products follows:
Croissant 4 Pack Bakers of Paris, PLU 241593
Chocolate Croissant 4 Pack Bakers of Paris, PLU 241595
The recalled products have “packed on” dates of 8/16/16 or earlier and “best by” dates of 8/18/16 or earlier. The products were distributed only to 18 Whole Foods Market stores in Northern California. A full list of affected stores is below.
Customers who have purchased this product at a listed Whole Foods Market store should discard it and may bring in their receipt for a full refund.
Consumers with questions may contact Bakers of Paris at 415-468-9100, ext. 2215 (Monday – Friday from 0800 to 1700 or customer-service@bakersofparis.com.
Product has been recalled from the following Whole Foods Market locations:
3000 Telegraph Avenue
Berkeley
CA
94705
2001 Market Street
San Francisco
CA
94114
5200 Dublin Blvd
Dublin
CA
94568
1765 California Street
San Francisco
CA
94109
1025 Gilman Street
Berkeley
CA
94710
690 Stanyan St
San Francisco
CA
94117
230 Bay Place
Oakland
CA
94612
3502 Mt. Diablo Blvd.
Lafayette
CA
94549
4800 El Camino Real
Los Altos
CA
94022
3950 24th Street
San Francisco
CA
94114
1150 Ocean Ave
San Francisco
CA
94112
774 Emerson Street
Palo Alto
CA
94301
450 Rhode Island
San Francisco
CA
94107
1250 Jefferson Ave
Redwood City
CA
94063
1010 Park Place San Mateo
CA
94403
100 Sunset Drive
San Ramon
CA
94583
399 4th Street
San Francisco
CA
94107
1333 E. Newell Ave.
Walnut Creek
CA
94596
John