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WormGuy

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  1. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-112-2016-release News Release Omni Custom Meats, Inc Recalls Roasted Chicken Quarters Due To Misbranding and Undeclared Allergens Class II Recall 112-2016 Health Risk: Low Nov 22, 2016 Congressional and Public Affairs Jeremy J. Emmert (202) 720-9113 Press@fsis.usda.gov WASHINGTON, Nov. 22, 2016 – Omni Custom Meats, Inc., a Bowling Green, Ky. establishment, is recalling approximately 191,695 pounds of marinated Roasted Chicken Quarters due to misbranding, specifically an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen which was not declared on the product label. The marinated Roasted Chicken Quarters were produced from Jan. 12 through Nov. 15, 2016. The following products are subject to recall: View Label PDF Only http://www.fsis.usda.gov/wps/wcm/connect/757c3e57-69b6-4743-ac02-467f2a362e17/112-2016-label.pdf?MOD=AJPERES 5,477 cases of 35-lb. heat sealed bags containing 52 pieces of “Roasted Chicken Quarters – Sea Salt, Cane Juice, Chicken Broth Powder, Canola Powder, Spices.” The products subject to recall bear establishment number P-2199 inside the USDA mark of inspection. These items were shipped to distributors in Georgia and Missouri. FSIS personnel discovered the problem on Nov. 21, 2016 during routine label verification activities. There have been no confirmed reports of illness or adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. 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. John
  2. http://www.fda.gov/Safety/Recalls/ucm530398.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. Sabra Dipping Company’s Recall Prompts Secondary Recall of Vegetable Products For Immediate Release November 21, 2016 Contact Consumers Taylor Farms 855-455-0098 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm530398.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos Following the Sabra Dipping Co., LLC’s ("Sabra’s") recall where select Sabra's products were recalled due to the potential of being contaminated with Listeria monocytogenes, Taylor Farms Tennessee, Inc., Taylor Farms Texas, Inc. and Taylor Farms Pacific, Inc. (all collectively referred to as “Taylor Farms”) are voluntarily recalling a limited number of products that contain Sabra's recalled products. The recalled products are labeled “Taylor Farms Veggie and Hummus Bistro Boxes” and “Schnucks Vegetable and Hummus Snack Trays” containing Sabra Hummus Classic 2 oz. dipping cups. The Taylor Farms products subject to the recall are limited to the code dates provided. No other Taylor Farms products are impacted by this recall. Product Description UPC Use By Dates Taylor Farms Veggie & Hummus Bistro Box 0 30223 01037 1 11/11/16 – 12/1/16 Schnucks Vegetable and Hummus Snack Tray 0 41318 09193 9 11/18/16 & 11/23/16 (Please refer to Sabra’s recall notice for details regarding individual Sabra items and lot codes/”Best Before” dates, also located on the lid or bottom of the dipping cups.) These products are being recalled because they have 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. Taylor Farms has not received any reports of illnesses associated with these recalled items. The recalled products were distributed from October 30, 2016 – November 18, 2016. The grocers involved have been instructed to remove any remaining product from their shelves and to dispose of any of the remaining product in their inventory. The recalled products were distributed in Arkansas, California, the District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, Nevada, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Virginia, Wisconsin, and West Virginia. Customers who have purchased these products are urged not to consume the products and should dispose of the recalled products immediately. Consumers may call for further information at (855) 455-0098 between the hours of 9 am (PST) and 5 pm (PST) Monday through Friday. Consumers with concerns about an illness from consumption of this product should contact a health care provider. John
  3. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm530336.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation 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: FindrWIRZ Guidewire System Lot Numbers: 01160568, 02160586, (no products shipped from this lot) 07160639 -150 Distribution Dates: June 1, 2016 to September 26, 2016 Manufacturing Dates: January 4, 2016 to July 22, 2016 Devices Recalled in the U.S.: 98 Device Use The FindrWIRZ Guidewire System is intended for use during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems. The system helps the positioning of over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg or wrist. This device has a hydrophilic lubricious coating, polytetrafluoroethylene (PTFE), to reduce friction between the device and blood vessels. Reason for Recall SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by issues with the device design or manufacturing processes. Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death. Who May be Affected Health care providers using this device during vascular procedures All patient groups undergoing procedures involving the FindrWIRZ Guidewire System What to Do On September 29, 2016, SentreHeart sent an Urgent Medical Device Voluntary Recall letter to all affected customers. The letter asked customers to: Identify and stop using the affected products Return the affected products to SentreHEART immediately Complete and return the response form via fax 650-354-1204 or email to customerservice@sentreheart.com Contact Information Health care professionals and consumers with questions are instructed to contact SentreHeart at (650)-241-6008 with any questions related to this recall. Date Recall Initiated September 29, 2016 How do I report a problem? Health care professionals and 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. John
  4. http://www.fda.gov/Safety/Recalls/ucm530154.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. Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance For Immediate Release November 18, 2016 Contact Consumers Tri-Coast Pharmacy Inc. pharmacist@tricoastrx.com 1-561-776-7510 Announcement Juno Beach, FL – Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry (list is attached below) due to Food and Drug Administration’s (“FDA”) concerns over the lack of sterility assurance of the drugs named in this recall. Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening. No portion of any lot of these medications has been found to be non-sterile, but the FDA is concerned that the conditions under which they were produced introduce a lack of sterility assurance for these products. To date, Tri-Coast Pharmacy has received no adverse event reports for these products. The recalled drug products were used for a variety of indications. All recalled products have a Tri-Coast Pharmacy Inc. label that includes the name Tri-Coast Pharmacy Inc., our logo, the drug name, lot number and the expiration date. In the event a patient is unsure if their product is on the list of recalled drugs, we ask that they call the pharmacy to inquire. The phone number is 1 (561) 776-7510 or toll free at 1 (877) 823-3284. Tri-Coast Pharmacy’s primary concern is to ensure patient safety. All patients and providers that received any sterile compounded products from Tri-Coast Pharmacy Inc. prepared between May 17, 2016 and November 17, 2016 and that remain with expiry, should take the following actions: · Quarantine any unused product until further instruction are received to facilitate the product being returned to Tri-Coast Pharmacy Inc. · Discontinue the use of any products contained in the recall · Please contact Tri-Coast Pharmacy Inc at 1 (561) 776-7510 or our toll free number 1 (877) 823-3284, Monday through Friday, 10am to 6pm EST. or email at pharmacist@tricoastrx.com to discuss the returning of any unused product associated with his recall. Patients should contact their physician or healthcare provider if they have experienced any problems that may be associated with using these products. Providers who have dispensed any sterile products prepared between May 17, 2016 and November 17, 2016 to a patient should contact the patient(s) to whom the product was dispensed and make the patient(s) aware of this recall. 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 and in cooperation with the U.S. Food and Drug Administration. Patient safety is the primary concern at Tri-Coast Pharmacy Inc. and we are taking this voluntary action out of an abundance of caution. Thank you. The following is a list of products to be recalled, 7-Keto DHEA 40 mg/mL Suspension 05312016C, 06292016B, 06282016E, 06082016F, 07142016B, 09272016F, 10182016B Adenosine-5 Monophosphate 100 mg/mL 08052016B Amino Energy Cocktail Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Niacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Lidocaine HCL 10mg/mL 06012016A, 07282016A Amino Acid Recover Eaze Phenylalanine (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + Tryptophan (L) 1.5 mg/ml + Threonine 1 mg/ml + L-Taurine 0.7 mg/ml 06072016C, 08162016E, 11012016H Ascorbic Acid 500 mg/mL 07192016WW, 07152016G, 08292016A, 10262016B BCAA Isoleucine (L) 15 mg + Leucine (L) 10 mg + Valine 40 mg + Lidocaine HCL 10 mg/ml 07222016A, 08162016C, 08042016A, 10102016C, 11012016I, 10172016B B-Complex Compound Thiamine HCL 100mg/Riboflavin-5-Phosphate 2mg/Pyridoxine HCL 2mg/Dexpanthenol 2mg/Niacinamide 100mg/Methylcobalamin 300mcg/ml 07262016E, 10262016E BiMix Phentolamine/Papaverine 0.06mg/1.8mg/mL 06092016B, 07212016C, 09162016A, 11012016A BiMix Phentolamine/Papaverine 1mg/30mg/mL 07222016H BiMix Phentolamine/Papaverine 2mg/30mg/mL 09302016D Calcium Gluconate 10% Injection 08172016A Calm Me Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10mg/ml 09212016A Dexpanthenol 250 mg/mL 08162016B GAC L-Glutamine/L-Arginine/L-Carnitine 25mg/100mg/200mg/mL 06172016A, 08092016B, 09262016A, 10132016E Glucosamine 200 mg/mL 10192016D Glutamine 25 mg/mL 08032016A Glutathione 200 mg/mL 06082016A, 07052016C, 08082016A, 09132016D, 10262016A HCG 5,000 IU Vial 06222016D, 06062016C, 07192016C, 07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F HCG/Hydroxycobalamin 5,000 IU/5mg Vial 06232016A, 07192016B, 08262016A, 08092016C, 09192016C, 10102016F, 11042016C, 10252016A HCG 11,000 IU Vial 06152016A, 07252016D, 07112016C, 08312016B, 08262016B, 08092016D, 08052016A, 09282016B, 09222016D,09072016A, 10252016J, 10182016D, 10102016H, 11042016A, 11012016E Infuvite IV Ascorbic Acid 200 mg + Vitamin A Acetate 330 IU + Vitamin D3 200 IU + Thiamine HCL 6 mg + Riboflavin-5-Phosphate Sod 3.6 mg + Pyridoxine HCL 6 mg + Niacinamide 40 mg + Dexpanthenol 15 mg + Vitamin 40E Succinate 10 IU + Phytonadione (Vitamin K1) 150 mcg/5-mL 07062016D, 08312016A, 08232016C, 08222016C, 08102016E, 08102016D, 08012016E, 09262016C, 09132016C IV Cocktail #2 Ascorbic Acid 500 mg/Magnesium Chloride 8 mg/Methylcobalamin 50 mcg/ Dexpanthenol 2.5 mg/Folic Acid 50 mcg/B-Complex Inj 0.02ml/Vitamin E 0.1 unit/Vitamin A 1 unit/mL 05252016D, 05202016A, 05182016C, 05092016C, 05022016C, 06132016D, 06072016A, 06062016A, 07282016E, 07252016G, 09122016A, 09192016B L-Arginine HCL 100 mg/mL 07282016H, 09282016E L-Carnitine 250 mg/mL 09132016F L-Tyrosine 10 mg/mL 07292016A, 07182016E, 08222016A, 10192016A Lipo-C Methionine 25mg/Inositol 50mg/Choline Chloride 50mg/Carnitine (L) 100 mg/ Methylcobalamin 1mg/ Thiamine HCL 50mg/Riboflavin- 5-Phosphate Sod 5mg/ Niacinamide 50mg/ Dexpanthenol 5mg/ Pyridoxine HCL 1.25mg/ Lidocaine HCL 10mg/mL 07282016B, 08242016B Lipotropic L-Carnitine 170 mg +Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10mg/ml 09022016A, 07282016C Lipotropic with MIC Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L- Carnitine 170 mg +Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 20mg/ml 06012016B, 07082016A, 10032016C, 08242016C Methylcobalamin 1,000 mcg/mL 05132016KK, 05262016A, 06092016A, 07262016B, 07062016C, 08292016B, 10132016F, 10252016K, 07262016C, 09152016C Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL 05232016A, 06282016B, 06212016A, 06142016A, 06072016E, 06022016B, 06022016A, 07262016H,07192016A, 07122016A,07082016D, 07062016B, 08302016B, 08232016D, 08162016D, 08092016E, 08042016F, 09122016E, 09272016D, 09272016B, 09202016A, 09132016A, 09072016B, 10112016D, 10042016B, 11022016A, 11092016A, 11082016A Myers Cocktail #4 Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg +Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL 06202016DD, 09132016B Myers Cocktail #5 Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg +Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL 07182016A MIC Ultra Cocktail Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20mcg/Pyridoxine HCL 2mg/ml 06132016B, 08042016B,08252016A Mineral Mix Schrader Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 1 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1 798mg/ml + Sodium Selenite 200 mcg/ml + Cupric Sulfate 1 mg/ml 05182016B, 08102016B Nandrolone Decanoate 200 mg/mL 07112016A, 08172016B, 09122016C, 10252016E Pyridoxine HCL 100 mg/mL 08162016A QuadMix 05242016A Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/mL QuadMix Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/mL 06162016B QuadMix Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mcg/mL 10262016H, 11032016C QuadMix Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mcg/mL 06072016F, 08112016C QuadMix Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mcg/mL 08102016F QuadMix Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/mL 07222016B QuadMix Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/mL 07252016E, 07192016E, 07052016B, 09142016A Sermorelin Acetate 6 mg 06062016D, 08022016A Sermorelin Acetate 9 mg 08022016B Sermorelin Acetate 15 mg 08152016B Sermorelin Forte 6 mg Sermorelin Acetate 3 mg/GHRP-6 3 mg 10192016A Sermorelin Forte 12 mg Sermorelin Acetate 6 mg/GHRP-6 6 mg 06152016C, 10242016C Sermorelin Forte Plus 18 mg Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg 05252016C, 07252016B, 09192016B Sermorelin Forte Plus 27 mg Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg 05252016B, 06232016B, 07152016B, 08262016D, 08152016A,08022016C, 09282016C, 10192016C, 10102016K, 10252016B Sermorelin GT Sermorelin Acetate 15 mgGHRP-2 5.4 mg/Theanine (L) 75 mg 06152016B, 07252016C, 08262016C, 09192016A, 10192016B, 10102016E, 10242016B Slim Shot Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1mg/Pyridoxine HCL 2.2mg/ml 06292016A, 08102016C, 10262016C Taurine 50 mg/mL 06282016C, 09062016C, 10242016A, 10212016A Testosterone Cypionate 100 mg/mL Sesame 07152016A, 08182016A, 09282016J Testosterone Cypionate 150 mg/mL Sesame 05122016B, 08012016C, 09262016D Testosterone Cypionate 200 mg/mL Grapeseed 05232016D, 06162016A, 06132016A, 07282016I, 08172016D, 08042016C, 09222016F, 09062016A, 11012016L, 10272016B, 10252016D, 08252016B, 11022016C Testosterone Cypionate 200 mg/mL Sesame Oil 05252016A, 06272016B, 07262016D, 07182016H, 07182016G, 08252016C, 08222016B, 08102016A, 09282016D, 09222016E, 09152016A, 09062016B, 10252016C, 10042016E Testosterone Cypionate/Zinc Gluconate 200mg/2mg/mL Sesame Oil 07262016A, 07132016C, 08302016A, 08042016D, 11012016K, 09202016D, 10032016B Testosterone Cypionate 250 mg/mL Sesame Oil 06272016A, 07252016A, 08242016A, 08112016B, 09212016B, 10252016L Testosterone Cypionate/Propionate 200mg/50mg/mL 07132016D, 11072016B Testosterone Cypionate/Enanthate 180mg/20mg/mL 07132016F Testosterone Cypionate/Enanthate/Propionate 160mg/20mg/20mg/mL 06082016C, 06012016C, 07222016B, 08042016E, 09012016A, 10032016A Testosterone Enanthate 200 mg/mL Sesame Oil 05232016C, 07132016G, 08122016A, 09012016B, 11012016J, 09272016A Testosterone Suspension 100 mg/mL 06292016C Testosterone Propionate 100 mg/mL 07272016A, 07052016A, 10132016A, 11072016A Tri-Amino Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/ml 07262016F, 09152016E, 08092016A TriMix Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL 05312016D, 08312016C, 08162016F, 08032016E TriMix Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL 07152016C, 09292016A TriMix Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL 05312016A, 05182016E, 07292016B, 07212016A, 08012016F, 09272016H, 09072016C, 09012016C, 11012016C TriMix Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL 06152016D, 07272016D, 10252016I, 10202016A, 10172016A TriMix Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL 07152016E, 08012016G, 09162016B, 10112016C, 11032016B TriMix Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL 06012016E, 09272016B, 10032016G, 11012016D TriMix Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL 05232016E, 05192016B, 06092016C, 06132016F, 05022016E, 06292016D, 06232016D, 06222016E, 06202016B, 06162016B, 06152016E, 06132016C, 06082016E, 06072016D, 06022016C, 06012016D, 07282016F, 07262016G,07222016E, 07222016D,07202016A, 07192016D,07182016C, 07152016F, 07132016B, 07082016C, 07062016E, 08292016C, 08092016F, 08052016C, 08042016J, 08042016H, 08032016D, 08022016E, 09072016D, 09272016C, 10132016C, 11012016B TriMix Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL 06282016A, 06222016C, 07182016D, 10202016B, 11102016D TriMix Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL 06022016E TriMix Alprostadil/Phentolamine/Papaverine 07282016G, 07142016D, 07082016E, 40mcg/2mg/60mg/mL TriMix Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL 07112016B, 09232016S, 09222016H, 09072016E, 10252016F, 11032016F TriMix Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL 08022016F Ultra Amino Blend Arginine HCL 150 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10mg/mL 06302016A, 06152016F, 08152016D Ultra Amino Energy Cocktail Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Niacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL 05232016B, 06082016B, 07272016C, 07152016H,08172016C, 09152016B, 10102016A, 11022016B, 10202016C Ultra Cocktail #2 Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL 05192016A, 05182016A, 08032016B, 09292016C, 08232016A Ultra Slim Shot Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2 mg/Lidocaine HCL 10mg/ml 06232016C, 07272016B, 08232016B, 09202016C, 10262016D Vitamin D3 100,000 Unit/mL Olive Oil 06062016E, 07282016D, 08152016C, 09092016A, 10042016A John
  5. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529791.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance Posted 11/21/2016 AUDIENCE: Pharmacy ISSUE: Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. See the press release for a listing of affected products and lot numbers. BACKGROUND: The recalled products were distributed nationwide to health care facilities from May 25 to October 31, 2016. RECOMMENDATION: Cantrell Drug Company will begin notifying its customers by email and phone and is arranging for the return of all recalled products. Consumers who have product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Cantrell Drug Company at 877-666-5222, Monday through Friday between 9 a.m. and 5 p.m. CST. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form 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 [11/18/2016 - Press Release - Cantrell] http://www.fda.gov/Safety/Recalls/ucm529776.htm John
  6. Folks I need to make a change in the way I post recalls. Hopefully this will only last for a few weeks but it could be several months. I am having major back problems that is also affecting my mental health. I can’t concentrate on things like I need to and some of these recalls take quite a bit of time. I have some that I had ready to post and I will do those in full form. After those are done I will only be posting the link that you will need to follow to read the full text. I will note what the recall is about and the amount as usual. I hope you will have patience with me until I get through this issue. John
  7. Folks I need to make a change in the way I post recalls. Hopefully this will only last for a few weeks but it could be several months. I am having major back problems that is also affecting my mental health. I can’t concentrate on things like I need to and some of these recalls take quite a bit of time. I have some that I had ready to post and I will do those in full form. After those are done I will only be posting the link that you will need to follow to read the full text. I will note what the recall is about and the amount as usual. I hope you will have patience with me until I get through this issue. I will post this in the Consumer Affairs section also. John
  8. I thought they did that on Thanksgiving day last year. I could be wrong. I wonder how they would freeze and thaw... John
  9. http://www.fda.gov/Safety/Recalls/ucm529981.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. Allergy Alert Issued on Mislabeled Product for Undeclared Milk and Soy in Heinz Homestyle Bistro Au Jus Gravy For Immediate Release November 19, 2016 Contact Consumers 1-866-572-3808 Media Lynne Galia lynne.galia@kraftheinzcompany.com 847-646-4396 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm529981.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos Allergy Alert Issued on Mislabeled Product for Undeclared Milk and Soy in Heinz Homestyle Bistro Au Jus Gravy Chicago – Approximately 500 cases of Heinz HomeStyle Bistro Au Jus Gravy are voluntarily being recalled because some of the jars may be mislabeled as Heinz Pork Gravy and therefore not labeled as containing milk and soy. People who have an allergy or severe sensitivity to milk or soy run the risk of a serious or life-threatening allergic reaction if they consume this product. There have been no consumer complaints or reports of illness related to this issue to date. No other sizes, varieties or code dates of Heinz Gravy are included in this recall. The following is being recalled: Product Packaging Description Case Unit BEST BY Code Date Individual Package BEST BY Date and Manufacturing Code Individual Package UPC Case UPC For Retailers: Heinz HomeStyle Gravy Bistro Au Jus Cases of 12oz glass Jar MU6F04 Best By 12/28/2017 NA NA 10013000798508 For Consumers: Heinz HomeStyle Gravy Pork Individual Packages 12oz glass Jar NA Best By 12/28/2017 MU6F04 4Q XX:XX 013000798907 NA Note: XX:XX designates the time stamp. We deeply regret this situation and apologize to any consumers we have disappointed. Consumers who purchased this product should not eat it. They should return it to the store where purchased for an exchange or full refund. Consumers with questions may contact the company at 1-866-572-3808 Monday through Friday, 9 a.m. to 6 p.m. Eastern, for a full refund. This product was distributed to retailers in the U.S. only. John
  10. FDA Removes Approval for the Use of PFCs in Food Packaging Based on the Abandonment November 21, 2016 In response to a petition filed on behalf of the 3M Corporation, the U.S. Food and Drug Administration is amending a food additive regulation to no longer authorize the use of two long-chain perfluorinated compounds (PFCs) used in “grease-proof” food packaging. 3M’s petition provided evidence that the use of these compounds, for which 3M stated it was the sole domestic and international manufacturer, has been completely and permanently abandoned by industry in the U.S. market. FDA’s action in amending this regulation is not based on a safety evaluation; rather, it is based on the abandonment of these uses. Although manufacturers have voluntarily stopped using these products, FDA’s action means that any food additive use of the PFCs covered by the regulations is no longer authorized. The FDA had authorized the use of long-chain PFCs for specific food-contact uses such as coatings on fast-food wrappers, to-go boxes, and pizza boxes before new scientific information brought safety concerns to light. In 2010, the FDA identified safety concerns through a comprehensive review of the available literature. These safety concerns included systemic and developmental toxicity in combination with biopersistence. The FDA then worked with industry to stop distribution of the long-chain PFCs most commonly used in food packaging at that time, which are authorized under food contact notifications. By October 1, 2011 these manufacturers had assured the FDA that they had voluntarily stopped distributing these long-chain PFCs. In January 2016, the FDA amended a food additive regulation to no longer allow the use of three long-chained PFCs, and is now amending this regulation to no longer authorize the remaining two long-chain PFCs. The FDA’s action means that any food additive use of these substances is no longer allowed. If a company wanted to use these products in the future as food additives, it would have to submit a new application to the agency and demonstrate that its use in food is safe. The publication of the final rule revoking the food additive regulation includes a 30 day period to file objections by any person adversely affected by this action. Objections can be submitted electronically to http://www.regulations.gov under FDA docket #FDA-2016-F-1153 starting on November 22, 2016. To submit objections by mail, send to FDA at: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 All objections must include the agency name and docket number. John
  11. http://www.fda.gov/Safety/Recalls/ucm529966.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. H-E-B Issues Precautionary Baby Food Recall For Immediate Release November 18, 2016 Contact Consumers H-E-B Customer Service 1-855-432-4438 Media Julie Bedingfield 210-867-6825 Announcement San Antonio, TX - H-E-B announced today that it has issued a precautionary recall of its entire H-E-B Baby Food 2 pack 4 oz. cups product line only. As of this afternoon, the H-E-B Baby Food 2 pack 4 oz. cups were removed from shelves out of an abundance of caution due to a customer report of a small piece of rubber found inside a single container of one variety of the product. There have been no reports of injury or illness associated with this isolated incident, however the company is taking the issue very seriously and taking all necessary precautions. “Though we have only received one report of a foreign material in H-E-B Baby Food 2 pack 4 oz. cups, as a company, we are committed to absolute and complete food safety. As a result of that commitment, coupled with the fact that we are dealing with a children’s product, we have made the decision to pull all of our H-E-B Baby Food 2 pack 4 oz. cups from our shelves,” said Winell Herron, H-E-B Group Vice President of Public Affairs, Diversity and Environmental Affairs. H-E-B has launched a full investigation into the incident and is working closely with its H-E-B Baby Food manufacturer to ensure all safety measures are being taken when manufacturing the product. The FDA has been made aware of the recall. H-E-B is encouraging customers who have any H-E-B Baby Food 2 pack 4 oz. cups in their pantries to return it to their nearest H-E-B store for a full refund. -more- The precautionary recall affects all lots of only H-E-B Baby Food 2 pack 4 oz. cups, including: PRODUCT NAME: UPC: HEB BABY BANANA PASSION FRUIT 4122081488 HEB BABY BANANA PINEAPPLE MNGO 4122084761 HEB BABY GREEN BEANS 4122005670 HEB BABY BANANA APPLE 4122000208 HEB BABY GREEN BEANS CORN 4122005671 HEB BABY BANANA 4122083207 HEB BABY SQSH SWT CORN TOMATO 4122066357 HEB BABY PEAR CARROT BLUEBERRY 4122005673 HEB BABY PEAS CARROTS 4122005685 HEB BABY VEG CHKPEA MIX 4122005668 HEB BABY BANANA CARROT MANGO 4122025540 HEB BABY APL CRRT PMPKN ZCCHNI 4122054253 HEB BABY SWT POT PMPKN ZCCHNI 4122066026 HEB BABY PEAS 4122005684 HEB BABY APPLE 4122081487 HEB BABY PEAR PINEAPPLE ZCCHNI 4122018455 HEB BABY PEAR PEAS ZUCCHINI 4122079172 HEB BABY SWEET POTATO 4122005686 Customers with any questions or concerns can contact H-E-B Customer Service at 1-855-432-4438 on Friday, Nov. 18 until 11 p.m., Saturday, Nov. 19 and Sunday, Nov. 20 from 9 a.m. to 7 p.m. and Monday through Friday, 8 a.m. to 8 p.m. thereafter. All times are Central Standard Time. About H-E-B H-E-B, with sales of more than $23 billion, operates more than 380 stores in Texas and Mexico. Known for its innovation and community service, H-E-B celebrated its 110th anniversary in 2015. Recognized for its fresh food, quality products, convenient services, and a commitment to environmental responsibility and sustainability, H-E-B strives to provide the best customer experience at everyday low prices. Based in San Antonio, H-E-B employs more than 96,000 Partners in Texas and Mexico and serves millions of customers in more than 300 communities. For more information, visit heb.com. John
  12. http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm529968.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery FDA Advises Consumers of Recall of Certain Sabra Hummus Products Consumers Should Not Eat Recalled Products Because of Possible Listeria Contamination November 19, 2016 Fast Facts Sabra Dipping Company LLC has recalled certain hummus products with a “Best Before” date on or before January 23, 2017, because the products have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause a serious, potentially life-threatening infection called listeriosis. The U.S. Food and Drug Administration advises consumers not to eat the recalled products and to throw them away. An FDA inspection of the Sabra Dipping Company LLC’s manufacturing facility in Colonial Heights, VA, revealed 27 swabs of the processing environment that contained Listeria monocytogenes. Analysis by pulse-field gel electrophoresis (PFGE) revealed that one of the strains of Listeria monocytogenes found during the recent inspection matches a strain found in a retail product sample collected in 2015, indicating this strain of Listeria monocytogenes may be persistent in the production environment. Symptoms of listeriosis include fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms. These symptoms can appear from a few days up to a few weeks after eating contaminated food. Listeriosis primarily affects older adults, pregnant women, newborns, and adults with weakened immune systems. What is the Problem and What is Being Done About It? On October 31, 2016, the FDA began an inspection of Sabra Dipping Company LLC’s manufacturing facility in Colonial Heights, VA. Nine environmental samples collected in food processing areas within the facility were positive for Listeria monocytogenes. On November 18, 2016, the FDA informed Sabra that an additional 18 environmental samples collected near food handling equipment were confirmed positive for Listeria monocytogenes. One of the strains of Listeria monocytogenes found during the recent inspection matches a strain found in a retail product sample collected in 2015, indicating this strain of Listeria monocytogenes may be persistent in the production environment. The FDA discussed the findings with Sabra including steps taken by Sabra since the inspection. On November 18, 2016, Sabra Dipping Company LLC initiated a voluntary recall of certain hummus products with a “Best Before” date on or before January 23, 2017, urging consumers to throw the product away. The products were distributed to retail outlets, including food service accounts and supermarkets, in the U.S. and Canada. Consumers can find code and “Best Before” dates on the lid of each package. Below is a list of the recalled products. UPC SKU Item 40822014700 300051 Sabra Hummus Caramelized Onion 10OZ 40822000017 300066 Sabra Hummus Classic 7OZ 40822011143 300067 Sabra Hummus Classic 10OZ 40822017497 300070 Sabra Hummus Classic 17OZ 40822014687 300074 Sabra Hummus Classic 30OZ 40822431156 300076 Sabra Hummus Classic 5LB 40822011112 300079 Sabra Hummus Classic 2OZ 40822011952 300080 Sabra Hummus Classic 4.56OZ 40822011235 300094 Sabra Hummus Garlic 7OZ 40822011242 300095 Sabra Hummus Garlic 10OZ 40822017510 300097 Sabra Hummus Garlic 17OZ 40822012256 300099 Sabra Hummus Garlic 32OZ 40822301121 300100 Sabra Hummus Garlic 30OZ 40822011990 300104 Sabra Hummus Garlic 4.56OZ 40822011921 300106 Sabra Hummus Jalapeno 10OZ 40822011341 300117 Sabra Hummus Olive 10OZ 40822011747 300132 Sabra Hummus Pine Nut 10OZ 40822127530 300134 Sabra Hummus Pine Nut 7OZ 40822990011 300136 Sabra Hummus Pine Nut 17OZ 40822012157 300139 Sabra Hummus Pine Nut 32OZ 40822012430 300142 Sabra Hummus Red Pepper 7OZ 40822011549 300143 Sabra Hummus Red Pepper 10OZ 40822017503 300146 Sabra Hummus Red Pepper 17OZ 40822328647 300148 Sabra Hummus Red Pepper 32OZ 40822301114 300150 Sabra Hummus Red Pepper 30OZ 40822434553 300151 Sabra Hummus Red Pepper 5LB 40822011969 300153 Sabra Hummus Red Pepper 4.56OZ 40822011433 300158 Sabra Hummus Supremely Spicy 7OZ 40822011440 300159 Sabra Hummus Supremely Spicy 10OZ 40822017558 300161 Sabra Hummus Supremely Spicy 17OZ 40822027540 300164 Sabra Hummus Spinach/Art 10OZ 40822014731 300166 Sabra Hummus Sun Dried Tomato 10OZ 40822027700 300266 Sabra Hummus Spinach/Art 32OZ 40822027588 300298 Sabra Hummus Spinach/Art 17OZ 40822990011 300501 Sabra Hummus Pine Nut 17OZ 40822017503 300502 Sabra Hummus Red Pepper 17OZ 40822020114 300593 Sabra Hummus Basil-Pesto 10OZ 40822330466 300736 Sabra Hummus Tuscan Herb Garden 32OZ 40822342049 301216 Sabra Hummus Classic 32OZ 40822342131 301271 Sabra Hummus Classic 4.56OZ 40822342209 301283 Sabra Hummus Garlic 23.5OZ 40822017497 301290 Sabra Hummus Classic 17OZ 40822342506 301430 Sabra Hummus Bold & Spicy 4.56OZ 40822017510 301480 Sabra Hummus Garlic 17OZ 40822342728 301481 Sabra Hummus Classic 2OZ 40822011648 301483 Sabra Hummus Lemon 10OZ 40822342735 301484 Sabra Hummus Red Pepper 2OZ 40822330381 301485 Sabra Hummus Tuscan Herb Garden 17OZ 40822010078 301511 Sabra Hummus Classic 2OZ 40822010047 301512 Sabra Hummus Classic 2OZ 40822342988 301566 Sabra Hummus SF Rosemary/Sea Salt 10OZ 40822343145 301585 Sabra Spreads Spicy Chili 8.5OZ 40822343138 301586 Sabra Spreads Garlic Herb 8.5OZ 40822343121 301587 Sabra Spreads Honey Mustard 8.5OZ 40822343114 301588 Sabra Spreads Salt & Pepper 8.5OZ 40822343671 301640 Sabra Hummus Taco 10OZ 40822344043 301705 Sabra Hummus 3 Pepper Chili 10OZ What are the Symptoms of Listeriosis? Listeriosis is a rare but serious illness usually caused by eating food contaminated with the bacteria called Listeria monocytogenes. Anyone who experiences fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or develops fever and chills while pregnant after eating products contaminated with listeria should seek medical care and tell their health care provider about eating the potentially contaminated food. Symptoms can appear from a few days up to a few weeks after consumption of the contaminated food. Read more about food safety tips for expectant mothers. Listeriosis, the third leading cause of death from food poisoning, targets pregnant women and their babies, people with weakened immune systems and those 65 years of age or older. Listeriosis hits these high-risk groups the hardest, accounting for at least 90 percent of reported Listeria infections and resulting in higher rates of hospitalization and death than most other foodborne bacteria. In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies. What Do Retailers Need to Do? Retailers should not serve or sell any of the recalled products and should dispose of them. If they do not know the source of their hummus, they should check with Sabra Dipping Company LLC. Wash and sanitize display cases and refrigerators where potentially contaminated products were stored. Wash and sanitize cutting boards, surfaces, and utensils used to cut, serve, or store potentially contaminated products. Wash hands with warm water and soap following the cleaning and sanitation process. Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross-contamination of cutting surfaces and utensils through contact with the potentially contaminated products. Regular frequent cleaning and sanitizing of cutting boards and utensils used in processing may help to minimize the likelihood of cross-contamination. Listeria can grow at refrigeration temperatures in foods. Listeria can also cross-contaminate other food cut and served on the same cutting board or stored in the same area. Retailers, restaurants, and other food service operators may wish to consider whether other foods available for sale could have been cross-contaminated from the potentially contaminated products, and should be discarded. Firms who have re-labeled, re-packed, or used the recalled products to produce new products that have not received a thermal kill step should contact the FDA Recall Coordinator in your state to determine whether or not you should initiate a new recall of your product(s). View FDA District Recall Coordinators for each state. What Do Consumers Need To Do? The FDA urges consumers to not eat any of the recalled products and to check their homes for the recalled hummus. To help avoid Listeria, consumers should follow these simple steps: Wash hands with warm water and soap for at least 20 seconds before and after handling food. Wash the inside walls and shelves of the refrigerator, cutting boards and countertops; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; then dry with a clean cloth or paper towel that has not been previously used. Wipe up spills in the refrigerator immediately and clean the refrigerator regularly. Always wash hands with warm water and soap following the cleaning and sanitization process. Additional recommendations for preventing listeriosis are available at the CDC Listeria website. Who Should be Contacted? Consumers who have questions about the Sabra Dipping Company LLC’s recall may call the company’s customer relations hotline at 1-866-265-6761 for additional information and http://www.sabrahummusrecall.com for product reimbursement.The FDA also encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern time, or to consult http://www.fda.gov. John
  13. http://origin-www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-110-2016-release News Release Wayne Farms LLC. Recalls Ready-To-Eat Chicken Breast Products That May Be Undercooked Class I Recall 110-2016 Health Risk: High Nov 18, 2016 Distribution List PDF http://origin-www.fsis.usda.gov/wps/wcm/connect/89084442-7565-426f-a0ac-adbda85b7afc/RC-110-2016-Retail-List.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=89084442-7565-426f-a0ac-adbda85b7afc Congressional and Public Affairs Gabrielle N. Johnston (202) 720-9113 Press@fsis.usda.gov WASHINGTON, Nov. 18, 2016 – Wayne Farms LLC., an Oakwood, Ga. establishment, is recalling approximately 4,059 pounds of ready-to-eat chicken products due to undercooking, resulting in the potential survival of bacterial pathogens in the products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The ready-to-eat grilled chicken breast items were produced on Aug. 1, 2016 and Aug. 29, 2016. The following products are subject to recall: View Labels PDF Only http://origin-www.fsis.usda.gov/wps/wcm/connect/f6300518-0259-4866-b125-c09611542336/110-2016.pdf?MOD=AJPERES 9-lb. foodservice bulk cases of “Fully Cooked Grilled Chicken Breast Fillets” with case code 22121. 22.5-lb. foodservice bulk cases of “Fully Cooked Flame Grilled Chicken Breast Fillets” with case code 22423. The products subject to recall bear establishment number “EST. 45411” or “P-45411” inside the USDA mark of inspection. These items were shipped to retail stores in Florida, Iowa, Minnesota, Missouri and North Dakota. The problem was discovered during a routine records review by the company when it was noted that a similar product had an appearance of being undercooked. There have been no confirmed reports of adverse health effects 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 Wayne Farms LLC. at 1-800-241-3110. Media with questions about the recall can contact Alan Sterling, Director Marketing, at (678) 450-3092. John
  14. http://www.fda.gov/Safety/Recalls/ucm529923.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. Nutra Manufacturing, Inc. Announces Nationwide Voluntary Recall of One Lot of GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement For Immediate Release November 16, 2016 Contact Consumers GNC Customer Service 1-888-462-2548 Media Greg Miller of Marketcom PR (212) 537-5177 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm529923.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos Pittsburgh, PA, Nutra Manufacturing, Inc. (“Nutra”) today announced that it is initiating a nationwide, voluntary recall of one lot of GNC Women’s Ultra Mega Time Release dietary supplement product sold in 180 count containers UPC 048107158910, lot number 3044FQ2024, with an expiration date of June 2018 due to the fact the product may contain an undeclared major food allergen, milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. The United States Food and Drug Administration is aware of this recall. This recall involves only GNC Women’s Ultra Mega Time Release 180 count with the lot number 3044FQ2024. The lot number can be found on the bottom of the product box and the side panel of the product label. No other GNC brand products or lots are part of the recall. The problem was discovered by Nutra at its manufacturing facility. There have been no cases of persons with milk allergies reporting reactions to the product. The affected product was distributed starting in August 23, 2016 through the present and is packaged in an HDPE plastic bottle with a child resistant closure. See below for a picture of the box of the product. As part of its priority to ensure the safety and quality of all of its products, GNC is working with Nutra on the voluntary recall by removing the specified product from retail store shelves. If you are in possession of a bottle of GNC Women’s Ultra Mega Time Release180 count, please check the lot number on the product label and do not consume the product if it contains the 3044FQ2024 lot number. Instead, return the product to the GNC retail location where it was purchased for a full refund. If you have any questions concerning this recall, please call GNC Customer Service, which is open weekdays from 8:00 am – 8:30pm EST, at 1-888-462-2548. For media inquiries, please contact Greg Miller of Marketcom PR at (212) 537-5177. John
  15. Thanks for the prayers! I have not heard from the neurosurgeon that I was to be referred to so I called my doctor's office. I was told no one told anyone about the referral. So they said they would call & then call me back which they did. Now I have to wait 89 more days to see this person. I was told the date could change & I would be notified if it does. And some people wonder why folks don't like the health care in this country. John
  16. http://www.fda.gov/Safety/Recalls/ucm529857.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. Request Foods, Inc. Issues Allergy Alert On Undeclared Eggs In GFS® Brand Cheese Manicotti For Immediate Release November 17, 2016 Contact Consumers Request Foods 1-800-748-0378 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm529857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos Holland, MI - Request Foods, Inc. is recalling certain 68 oz. (4 LB 4 OZ) pans of GFS® Cheese Manicotti because the product inside may be Chicken Cannelloni, which contains egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Cheese Manicotti was distributed by Gordon Food Service to retail stores, restaurants and other foodservice operators in FL, IL, IN, KS, KY, MI, MO, OH, PA, TN, WI and WV. The pans are labeled as Cheese Manicotti but may have the Chicken Cannelloni product inside the pan. These mislabeled pans were distributed in cases/boxes marked as GFS® Chicken Cannelloni. The recalled products include: Individual TIN PANS of GFS® Cheese Manicotti with Julian lot code 15268 CASES of GFS® Chicken Cannelloni with Julian lot code 15268 Only products with lot code 15268 are subject to this recall. No other lot codes or products are included in this recall. The lot code can be found on the long side of the tin pan and the long side of the case. No illnesses have been reported to date in connection with this issue. The recall was initiated after a consumer reported that a pan labeled Cheese Manicotti instead contained Chicken Cannelloni. Consumers who have sensitivity to eggs and have purchased affected product with lot code 15268 should not consume the products and return it to the place of purchase for a full refund. Consumers with questions may contact Request Foods at 1-800-748-0378. The consumer lines are open Monday through Friday, 7:00 am to 5:00 pm John
  17. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-109-2016-release News Release La Quercia Recalls Dried Pork Products Due To Insufficient Dehydration Class I Recall 109-2016 Health Risk: High Nov 17, 2016 Congressional and Public Affairs Julie Schwartz (202) 720-9113 Press@fsis.usda.gov WASHINGTON, Nov. 17, 2016 – La Quercia, a Norwalk, Iowa establishment, is recalling approximately 932 pounds of cured, dried pork loin products due to insufficient dehydration, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Insufficient dehydration could lead to an outgrowth of harmful bacteria. The whole and sliced pork loin items were produced on various dates between June 3, 2016 and Nov. 2, 2016. The following products are subject to recall: View Labels PDF format http://www.fsis.usda.gov/wps/wcm/connect/3921349d-cf38-4949-acaa-5e0aa415d658/109-2016-labels.pdf?MOD=AJPERES 2.65-lb. vacuum-sealed package containing one piece of “LOMO AMERICANO” with a best by date of 11/08/17 and lot #Z16D04V115516. 2.65-lb. vacuum-sealed package containing one piece of “LOMO AMERICANO” with a best by date of 10/31/17 and lot #Z16D04V116016. 1.5-lb. package containing 20 slices of “SLICED LOMO AMERICANO. 2oz” with a best by date of 02/07/17 and lot #P17B07C128416. 1.5-lb. package containing 20 slices of “SLICED LOMO AMERICANO. 2oz” with a best by date of 02/21/17 and lot #P17B21C129816. 1.5-lb. package containing 20 slices of “SLICED LOMO AMERICANO. 2oz” with a best by date of 02/18/17 and lot #P17B18C129516. 1.5-lb. package containing 20 slices of “SLICED LOMO AMERICANO. 2oz” with a best by date of 03/02/17 and lot # P17C02C130716. 1.5-lb. package containing 20 slices of “SLICED LOMO AMERICANO. 2oz” with a best by date of 02/28/17 and lot #P17B28C130516. The products subject to recall bear establishment number “EST. 31797” inside the USDA mark of inspection. These items were shipped to distributors and retail locations in California, Colorado, Illinois, Indiana, Iowa, Massachusetts, New York, Oregon, Texas, and Virginia. The problem was discovered when FSIS inspection personnel found off-odor Lomo Americano product at the La Quercia establishment. There have been no confirmed reports of illnesses 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 Stephanie Bates, Inside Sales, at (515) 981-1625. Media with questions about the recall can contact Ruth Holbrook, Marketing Director, at (515) 981-1625. John
  18. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-108-2016-release News Release Morty Pride Meats, Inc. Recalls Pork Barbeque Products Due To Misbranding and Undeclared Allergens Class II Recall 108-2016 Health Risk: Low Nov 17, 2016 Congressional and Public Affairs Veronika Medina (202) 720-9113 Press@fsis.usda.gov WASHINGTON, Nov. 17, 2016 – Morty Pride Meats, Inc., a Fayetteville, N.C. establishment, is recalling approximately 237,891 pounds of pork barbeque products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were produced with Worcestershire sauce that contains soy, a known allergen which was not declared on the finished product label. The pork barbeque items were produced and packaged from Nov. 15, 2014 through Nov. 11, 2016. The following products are subject to recall: View Labels PDF Only http://www.fsis.usda.gov/wps/wcm/connect/87ea636f-6254-43b9-98d6-a7f7844d9b77/108-2016-labels.pdf?MOD=AJPERES 5-lb. of vacuum sealed bags of “Morty Pride Pork Barbeque, Electronically Cooked.” 12-oz of plastic cups of “Morty Pride Premium Pork Barbeque, Electronically Cooked.” The products subject to recall bear establishment number “EST. 6668” inside the USDA mark of inspection. These items were shipped to institutions and retail locations in North Carolina and South Carolina. The problem was discovered by FSIS inspection personnel during a random label verification on Nov. 16, 2016. There have been no confirmed reports of illness, injury, or 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. Consumers and media with questions about the recall can contact Mickey Hudson, President, at (910) 483-6004. John
  19. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery FDA News Release FDA approves Intrarosa for postmenopausal women experiencing pain during sex For Immediate Release November 17, 2016 Release The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse. "Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). "Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA." Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse. The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Intrarosa is marketed by Quebec-based Endoceutics Inc. John
  20. http://www.fda.gov/Safety/Recalls/ucm529501.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. The Popcorn Shoppe Issues Allergy Alert on Undeclared Milk and Soy in Olde Tyme Recipe Popcorn Balls, Edwards Orchard Popcorn Balls and Edwards Orchards West Popcorn Balls For Immediate Release November 16, 2016 Contact Consumers Melissa Molyet (567) 207-5432 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm529501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos The Popcorn Shoppe in Tiffin, Ohio is voluntarily recalling its Olde Tyme Recipe Popcorn Balls, Edwards Orchard Popcorn Balls and Edwards Orchard West Popcorn Balls (4 individually wrapped 5oz. popcorn balls in a clear plastic bag) due to an undeclared milk and soy allergen. This recall has been initiated due to the ingredient label not stating the milk and soy allergen. People who have an allergy or severe sensitivity to milk and soy run the risk of a serious or life-threatening allergic reaction if they consume this product. Individuals exhibiting signs or symptoms of food bourne illness or allergies should contact a physician immediately. Products were available for sale at retail locations in Illinois and Ohio. An Ohio Department of Agriculture inspector discovered the mislabeling issue during a routine visit. There have been no reports of illness to date involving products addressed in this recall. Customers with a milk and/or soy allergies or sensitivity who have purchased the affected product should dispose of it or return it to The Popcorn Shoppe for a replacement. Consumers with questions regarding this recall can contact Melissa Molyet at (567) 207-5432 Monday – Friday 9:00 am. - 5:00 pm. EST. John
  21. https://www.cpsc.gov/Recalls/2017/Skidders-Footwear-Recalls-Childrens-Shoes Skidders Footwear Recalls Children’s Shoes Due to Laceration Hazard; Sold Exclusively at Meijer Stores Recall date: November 16, 2016 Recall number: 17-033 Recall Summary Name of product: Children’s shoes Hazard: The rivets on the shoes have sharp edges, posing a laceration hazard. Consumer Contact: Consumers should immediately take the recalled shoes away from children and contact Skidders Footwear to receive a full refund. Recall Details Units: About 5,500 Description: This recall involves Skidders Footwear children’s canvas tennis shoes sold in three sizes: 12M, 18M and 24M. The shoes have white rubber bottoms and come in three different colors: navy blue fabric with orange rivets and laces, gray fabric with green rivets and laces, and denim colored fabric with pink rivets and laces. Incidents/Injuries: The firm has received three reports of the rivets scratching the feet of the wearer. No injuries have been reported. Remedy: Consumers should immediately take the recalled shoes away from children and contact Skidders Footwear to receive a full refund. Sold Exclusively At: Meijer stores located in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin, from August 2016 through October 2016 for about $10. Importer(s): Skidders Footwear Inc., of New York Distributor(s): Skidders Footwear Inc., of New York Manufactured In: China John
  22. http://www.fda.gov/Safety/Recalls/ucm529342.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. 4C Foods Corp. Voluntarily Recalls 4C Grated Cheese, Homestyle Grated Cheese, and Cento Grated Cheese Brands NET WT. 6 OZ Glass Jars Because of Possible Health Risk For Immediate Release November 15, 2016 Contact Consumers 4C Foods Corp. 866-969-1920 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm529342.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos 4C Foods Corp. is voluntarily recalling 4C Grated Cheese, Homestyle Grated Cheese, and Cento Grated Cheese Brands due to possible contamination with Salmonella. Other 4C Foods products, including any other cheese products, are not impacted by this recall. Salmonella is an organism that 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, 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. This recall was of a nationwide distribution and includes the following products, which were packed in 6 oz. vacuum-sealed glass jars, with BEST BY dates between November 12, 2016 and November 12, 2018 and packaged in cases of either 6 or 12 jars per case: 4C All Natural Parmesan Grated Cheese (UPC 41387-33126) 4C All Natural Parmesan/Romano Grated Cheese (UPC 41387-37126) 4C All Natural 100% Imported Italian Pecorino Romano Cheese (UPC 41387-77126) 4C HomeStyle All Natural Parmesan Grated Cheese (UPC 41387-32790) 4C HomeStyle All Natural Parmesan/Romano Grated Cheese (UPC 41387-11627) 4C HomeStyle All Natural 100% Imported Italian Pecorino Romano Cheese (UPC 41387-12302) Cento Parmesan Grated Cheese (UPC 70796-90502) Cento Romano Grated Cheese (UPC 70796-90501) Although no illnesses have been reported, we are voluntarily recalling these products out of an abundance of caution after FDA testing revealed the issue. Consumers are asked to return the product to the place of purchase for a full refund. Retail stores and distributors are requested to immediately remove and discard any of the above items from the shelves and warehouses. 4C Foods Corp. will reach out to all retailers and distributors with additional information. Please contact 4C Foods Corp. at 866-969-1920 Monday- Friday, 9:30 AM to 4:30 PM (Eastern Time), with any inquires. This recall is being made with the knowledge of the US Food and Drug Administration. John
  23. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm529363.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery Public Notification: ABX Weight Loss contains hidden drug ingredient 11-16-2016 The Food and Drug Administration (FDA) is advising consumers not to purchase or use ABX Weight Loss, a product promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. FDA laboratory analysis confirmed that ABX Weight Loss 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 people and may present a significant risk for people 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
  24. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-107-2016-release News Release Piccadilly Fine Foods Recalls Beef Shepherd’s Pie Due To Misbranding and Undeclared Allergens Class II Recall 107-2016 Health Risk: Low Nov 15, 2016 Congressional and Public Affairs Autumn Canaday (202) 720-9113 Press@fsis.usda.gov WASHINGTON, Nov. 15, 2016 – Piccadilly Fine Foods, a Santa Clara, Calif. establishment, is recalling approximately 144 pounds of beef products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were produced with Worcestershire sauce that contains anchovies (fish), a known allergen which was not declared on the finished product label. The beef shepherd’s pie items were produced on Sept. 29, 2016 and Oct. 20, 2016. The following products are subject to recall: View Label http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-107-2016-release/!ut/p/a1/jZFfa4MwFMU_yx58jLmpxdm9ieBatyqlrLN5GdHGPyxNJGaO7tMvblDosKy5L8nldzj35GKKc0wlG9qamVZJJsY39d9gAz5ZRJBkcRjDKvXiXZA-Esh8C-wvgAUZgd0me4oiCFLvRv2VE8J_-uQGg5leR-sa046ZBrWyUjjXvGRCoJL1HDFdNu3AcX6-zID4Z4bAPRobSHPBLY9fMb00BWLLmm7nyyT1IJv_BSZ-5Re4HtvmqoUqflawD2XhBTaA5hXXXLsf2rYbY7oHBxwQrXzv3VoNBy7s-PrklurowJSwUb3B-aQAd8eX_Os5rLYrRIvT5903okoKrQ!!/#label 4 cases of 8 oz. plastic sealed packages containing “BEEF SHEPHERD’S PIE With Vegetables, Made with Beef Chuck Steak,” with a case and lot code of “295-16” and a package date of 10/21/2016. 8 cases of 8 oz. plastic sealed packages containing “BEEF SHEPHERD’S PIE With Vegetables, Made with Beef Chuck Steak,” with a case and lot code of “274-16” and a package date of 9/30/2016. The products subject to recall bear establishment number “EST. 9216” inside the USDA mark of inspection. These items were shipped to retail locations in California. The problem was discovered by FSIS inspection personnel during normal inspection activities on November 10, 2016. Products produced prior to September 29, 2016 used a different brand of Worcestershire sauce that did not contain anchovies as an ingredient. There have been no confirmed reports of illness or 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. Consumers and media with questions about the recall can contact Nicholas Gutierrez, vice president, at (408) 246-1200. John
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