On October 8th, 2014 Customed, Inc. initiated a recall of sterile convenience surgical kits-trays, bags (known as “Convenience Kits”), and New Lots Added as follow-up to the June 3, 2014 Class I recall of 233 sterile convenience surgical kits. The Convenience kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection.
FDA finalizes menu and vending machine calorie labeling rules
The U.S. Food and Drug Administration today finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants, similar retail food establishments and vending machines with 20 or more locations to provide consumers with more nutritional information about the foods they eat outside of the home. The rules are required by the 2010 Patient Protection and Affordable Care Act.
Natura Pet Recalls 5 Lots of Dry Cat and Dry Ferret Food due to Vitamin Insufficiency
Natura Pet Products has initiated a limited, voluntary recall of certain dry cat and dry ferret food lots produced in its Fremont, Nebraska facility. Due to a formulation error, these products contain insufficient levels of vitamins and excess minerals.
Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules
urobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.
Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.
FDA warns against using laparoscopic power morcellators to treat uterine fibroids
Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
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 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.