Drug Recalls
Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination
FOR IMMEDIATE RELEASE - Hawthorne, NY, December 27, 2021 ─ Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing.
Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FOR IMMEDIATE RELEASE – 12/28/2021 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure firm voluntarily recall all the marketed 33 batches having valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.
Food & Beverage Recalls
GHGA, LLC. Issues Allergy Alert on Undeclared Fish in Chicken Salad Croissants
January 3, 2022, Conley, GA – GHGA, LLC. is voluntarily recalling 266, 7.8 oz. packages of Chicken Salad Croissants due to undeclared fish. People who are allergic to fish run the risk of serious or life-threatening allergic reaction if they consume this product
The recalled product was shipped to Kroger stores in Alabama, Georgia, and South Carolina on 12/30/2021.
The recalled Chicken Salad Croissants are packaged in 7.8 oz. clear plastic clamshells, with UPC 8 26766 15578 1, and marked with Sell-by Date 01/04/22 on the front of the package. Photos of the recalled product and label are below. No other products or lots are affected by this recall.
HAIFA SMOKED FISH of Jamaica, NY is expanding their recall of Turbot Cold Smoked 8 oz Packages to include 920 LB of Turbot from Lots 97, 223, 299, 321. The products 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.
Poppies International, Inc. Battleboro, North Carolina Issues Voluntary Recall on Certain Lots of Chocolate Enrobed and Cream Puff Products Due to Possible Presence of Metal
Poppies International, Inc. of Battleboro, NC is issuing a voluntary recall of selected products that were made during December 7-10, 2021, due to the possible presence of small metal fragments. The issue was discovered during production. No injuries or incidents have been reported in connection with the recalled items. See below for product list, UPCs, and “best before” dates, which may be found on the side of the containers.
Any consumers who have purchased or received any of the products described below should immediately discontinue use of the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at info@delizza.us or 252-428-7118, Monday through Friday between 9am-5pm EST. More information can be found at www.delizza.us/press
Relish Foods, Inc Recalls Frozen Tuna Steaks Because of Possible Health Risk
On December 27, 2021, Relish Foods, Inc of El Segundo, California voluntarily initiated the recall of Frozen Pacific Fusion Brand 10 oz Tuna Steaks. The recall was the result of a consumer complaint whereafter sampling by FDA revealed that the product has potential to contain elevated levels of histamines which can produce an allergic reaction called scombroid fish poisoning. Symptoms, including a tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea, can appear within minutes to several hours after eating the affected fish. If symptoms are severe, an individual should seek immediate medical attention for treatment. Relish Foods Inc is continuing the investigation with FDA as to what caused the problem.
Product was distributed in Northern California and made for sale at Save Mart Supermarkets and Lucky Stores from October 6th, 2021 potentially up to December 27th, 2021. Product was sold to consumers as frozen 10 oz tuna steaks. 10 oz tuna steaks sold individually would have been labeled with the following dates and production code: Production Date : July 2021 Best Before : July 2023 R11G2821D22A D2091A. This information can readily be found on the packaging of the individual tuna steaks in the top right corner:
Dianne's Fine Desserts Issues Allergy Alert on Undeclared Pecan Allergen in Sienna® Chocolate Decadent Brownie
Dianne's Fine Desserts of Newburyport, MA 01950 is recalling 1,480 trays of Sienna® Chocolate Decadent Brownies due to a mis-pack, resulting in an undeclared tree nut (pecan). People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products.
The impacted product, listed below, was distributed through Gordon Food Service (“GFS”) in retail and wholesale stores in WI, MI, FL, OH, and PA.
Trays of GFS Item #541850 Sienna® Chocolate Turtle Brownies, which contains pecans, may be labeled as GFS Item #226240 GFS Sienna® Chocolate Decadent Brownies, which do not contain pecans, thus resulting in an undeclared allergen. The impacted lot is 6Z1L24. Sienna® Chocolate Decadent Brownies can be identified by the name and product image on the tray. Tray size is 16.5 x 12.5. x 2 inches. The lot code can be found on the top label of the tray.
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