The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.
FDA takes enforcement action against Michigan sandwich company
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.
FDA issues additional guidance for outsourcing facilities that compound sterile human drugs
Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
FDA issues additional guidance for outsourcing facilities that compound sterile human drugs
Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
Kozy Shack Enterprises, LLC Issues Allergen Alert on Unlabeled Foodservice Chocolate Pudding Cups
Kozy Shack Enterprises, LLC is voluntarily recalling certain items of its Foodservice Kozy Shack Simply Well Chocolate Pudding 4 oz. cups because they contain undeclared milk and lack product labeling. 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.
Baxter Initiate Voluntary Recall of One Lot of Highly COncentrated Potassium Chloride Injection In The U.S. Due to Mislabeled Overpouch
Baxter International Inc. is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the high-risk patient population – patients prone to severe electrolyte imbalance – this hazardous situation may lead to serious, life-threatening adverse health consequences
Evershing International Trading Issues Allergy Alert on Undeclared Milk in Vinacafe Brand Coffee – Wake Up Weasel Instant Coffee mix 3-in-1
Evershing International Trading is voluntarily recalling Vinacafe Brand Wake Up Weasel Instant Coffee mix 3-in-1 after learning that the product may contain Sodium Caseinate ( a Milk derivative), a Milk allergen, and Soy extract, a Soy Allergen, that is not declared on the products’ ingredient statement. People who have an allergy or severe sensitivity to Milk and/or Soy have the risk of serious or life-threatening allergic reaction if they consume this coffee.
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FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
REFA Enterprises, LLC Issues Voluntary Nationwide Recall of Forever Beautiful Bee Pollen Due to Undeclared Sibutramine and Phenolphthalein
REFA Enterprises, LLC is voluntarily recalling one lot of each: Forever Beautiful Bee Pollen (UPC # 6333090804632), Forever Beautiful Infinity UPC # 633090804649), to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.