The U.S. Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.
GE Pharma, LLC Announces a Recall of Dietary Supplement Creafuse Powder Due to Possible Health Risk
Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA). DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
Schwebel Baking Company Voluntarily Recalls Schwebel’s Golden Rich Buns With Honey Due to Undeclared Eggs
Schwebel Baking Company today recalled 18,979 units of Golden Rich Buns with Honey due to mislabeling and undeclared egg. Through the package validation process the problem was discovered.
FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines
The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.
Talenti® Gelato & Sorbetto Issues an Allergy Alert for Undeclared Allergen (Almonds) in Talenti German Chocolate Cake Gelato Pints
Talenti® Gelato & Sorbetto is voluntarily initiating a product recall of Talenti German Chocolate Cake Gelato pints with the UPC # 1 8685200063 1 with a BEST BY DATE of 11/04/2014 M1, 11/24/2014 M1, and 11/24/2014 M2 as a precautionary measure. The recall was initiated after it was discovered by the firm that the product may contain undeclared almonds.
Leiter’s Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor
Leiter’s Compounding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter’s Compounding Pharmacy’s independent testing laboratory. The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
Bubbles Baking Co. Issues an Allergen Alert for Undeclared Milk and Soy in First Street Label Blueberry Muffins, 14 oz. 9 Trays/ Case and Blueberry Loaf, 16 oz. 12 Trays/Case
Bubbles Baking Co. is voluntarily recalling 9,229 cases of Blueberry Muffin 14 oz and Blueberry Loaf Cake 16 oz. due to undeclared milk and soy allergen. People who have allergies to milk and soy run the risk of serious or life-threatening reactions if they consume these products.
Park Compounding: Sterile Medication Recall – Concerns of Sterility Assurance at Testing Vendor
Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials, to the consumer level.
FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics
The U.S. Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories.