Food and Drug Administration--Recalls/Safety Alerts
Recall Information from FDA
08/13/2018 05:15 PM
World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads Contamination
World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom+CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, recalled due to Salmonella contamination, where Blissful Remedies was listed as the recalling firm instead of World Organix LLC. To date, World Organix LLC has not received reports of adverse events related to these recalls.
08/10/2018 04:25 PM
Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.
08/09/2018 02:50 PM
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).
08/04/2018 01:14 PM
Voluntary Recall of Hostess Cookies 'n Creme Brownies
Hostess Brands, LLC has become aware that the "Contains" statement on Hostess Cookies 'n Creme Brownies does not list "egg" as an allergen. Although the ingredient list on the packaging identifies "egg" as an ingredient, the "Contains" statement, which is designed to further alert consumers of allergens in the products, does not include "egg".
08/02/2018 05:11 PM
HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen
HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical treatment or hospitalization was not required.
08/01/2018 06:10 PM
Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging
Sweet Earth Foods is initiating a voluntary recall of a limited amount of 8-ounce packages of Sweet Earth Aloha BBQ Quesadilla due to mismatched packaging, resulting in undeclared egg and milk allergens. People who are allergic to eggs or milk could have a serious or life- threatening reaction if they consume this item. A UPC code of 016741000551 appears on the back of the package. The “best by” date of 6/28/19 and lot number of 8149 appears on the side of the package.
07/31/2018 04:18 PM
AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material
East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was found to contain silicone material. This problem was discovered as a result of two product complaints in which the contents of one vial from batch PP0317012-A was found to contain a glass particle and the contents of one vial from batch PP0317059A was found to contain a silicone particle.
07/31/2018 10:36 AM
ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle
ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, weakness, shortness of breath and possible death.
07/28/2018 03:28 PM
Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is 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.
07/27/2018 01:56 PM
TeaSource Issues Allergy Alert on Undeclared Almonds in Product
TeaSource of Roseville, MN is recalling Roasted Chestnut loose leaf tea, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product
07/25/2018 12:04 PM
AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk
Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.
07/25/2018 09:21 AM
Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers
As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard. This could create conditions that could allow for the growth of Clostridium botulinum (C. botulinum), a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
07/24/2018 04:22 PM
Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers
Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. No other Pepperidge Farm products in the U.S. are subject to this recall.
07/23/2018 04:34 PM
Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread
As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and supplier. No illnesses have been reported in connection with the recalled items. See below for list of UPC #s and “best by” dates.