The U.S. Food and Drug Administration announced today that on Dec. 4, 2013, a Livingston, Mont., dietary supplement maker was found in civil contempt of court for repeatedly violating the terms of a consent decree of permanent injunction that resolved a 2010 civil case against the company and its owner.
Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance
Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall.
FDA allows marketing of new stent for treating pseudocysts of the pancreas
The U.S. Food and Drug Administration today allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts (fluid and tissue filled cavities) that form in the pancreas and are next to the stomach or small intestine. This is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
Bee International Expands Allergy Alert on Undeclared Egg in "Sweet Spots"
Bee International, Inc. of Chula Vista, CA is recalling its 2oz. packages of candy “Sweet Spots” because they may contain undeclared egg protein. People who have allergies to egg may run the risk of serious or life-threatening allergic reaction if they consume this product.
Megabusiness LLC Issues Alert on Undeclared Sulfites in Del Campo Papa Seca / DRY Potato 24×14 oz.
Megabusiness LLC of Danbury, CT is recalling Del Campo Papa seca / DRY POTATO 24×14 oz. because they contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.
Blooming Import Inc. Issues an Alert on Undeclared Sulfites in Farmer Brand Dried Lily Flowers
Blooming Import Inc at 45 Bowne Street, Brooklyn, NY 11231 is recalling Farmer Brand Dried Lily Flowers because they contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
Stone Independent Research, Inc. Issues Allergy Alert on Undeclared Milk in EnhanceRx Dietary Supplement
Stone Independent Research, Inc. of Syracuse, NY is recalling 15,657 units of EnhanceRx, a dietary supplement, because it contains undeclared milk (whey protein). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.