FDA/USDA ~~ July 2017 Alerts & Safety pg2

Updated information is now available. A list of retail consignees has been posted for recall 084-2017, Stefano’s Foods, Inc. Recalls Meat Products Due To Misbranding and Undeclared Allergen (Jul 24, 2017).
Bateman Recalls Poultry Products Due To Misbranding And An Undeclared AllergenBateman, a West Sacramento, Calif. establishment, is recalling approximately 20,297 pounds of poultry products due to misbranding and an undeclared allergen.
Man of Steel Issues Voluntary Nationwide Recall of Man of Steel 1 and Man of Steel 2 Due to Tainted Supplements

07/31/2017 10:39 AM EDT

Sacramento, California, Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil.
ICU Medical Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

07/28/2017 06:03 PM EDT

ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.
Vibrant Health Products Issues Allergy Alert On Undeclared Egg In LiveGfree Gluten Free Classic Soft White Hamburger Buns
07/29/2017 06:52 PM EDT

Vibrant Health Products, a family-owned bakery in Abbotsford, B.C., Canada, has voluntarily recalled one lot of liveGfree Gluten Free Classic Soft White Hamburger Buns due to a packaging error. As a result, this product may contain undeclared egg.
Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue

07/28/2017 11:46 AM EDT

Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue
Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

07/27/2017 12:05 PM EDT

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.

07/26/2017 12:01 PM EDT Hy-Vee, Inc. based in West Des Moines, Iowa, is voluntarily recalling eight Hy-Vee brand pizzas that were sold at its six Minneapolis-area stores because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA Investigates Multiple Salmonella Outbreak Strains Linked to Papayas 07/25/2017 07:35 PM EDT
Updated information is now available. A list of retail consignees has been posted for recall 065-2017, Conagra Brands, Inc. Recalls Spaghetti and Meatball Products Due To Misbranding and Undeclared Allergens (Jun 9, 2017)
EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine

07/24/2017 10:16 PM EDT

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri’s Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil

07/21/2017 03:40 PM EDT

Charlotte, NC, Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, [1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry], distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED).
The FDA is advising consumers not to eat Caribeña brand Maradol papayas because they are linked to an outbreak of salmonellosis. Maradol papayas are green before they ripen and turn yellow, so consumers should not eat Caribeña brand regardless of the color. If anyone has these papayas in their home, they should dispose of them immediately. These can be identified by a red, green and yellow sticker shown here.
Papaya samples taken by MDH from a Baltimore retail location tested positive for the strains of Salmonella Kiambu and Thompson found in ill people.
CDC is advising consumers not to eat any Maradol papayas. FDA continues its traceback investigation. At this time, Caribeña brand papayas from Mexico have been identified as a brand linked to these illnesses. Additional brands will be announced as the information becomes available.
CDC reports 47 cases,12 hospitalizations and one death from 12 states in the Salmonella Kiambu outbreak. The states involved are IA, KY, LA, MA, MD, MN, NJ, NY, PA, TX, UT and VA. CDC is working to collect additional information to determine whether the recent Salmonella Thompson illness in Maryland is part of this multistate outbreak.