Weekly FDA Enforcement Report For Drugs 10/29/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 29, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily, or the FDA initiates the action. View the recalls by Classification.

Classification I Drug Recall

A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.

No Class I recalls this week.

Classification II Drug Recall

A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.

• Aidarex Pharmaceuticals recalled Ciprofloxacin 500 mg tablets because a Tramodol 50 mg tablet was found in a bottle of Ciprofloxacin. Tramadol is a narcotic-like pain reliever used to treat moderate to severe pain.
• Bio-pharm recalled Rugby Children's Pain and Fever Acetaminophen Oral Suspension due to superpotentcy at the 6-month time point.
• Qualitest Pharmaceuticals recalled Children’s Q-PAP, Acetaminophen in various flavors because the drug was superpotent at the 12-month time point.
• New Gpc recalled Alcosulph Moisturizing Cream, Mustercreme, Ferrol Expectorant, Whitfield Lotion and Ointment, and Rector's Remedy Ointment because they are not approved for sale in the U.S. New Gpc is a private company in the Caribbean. The FDA rejected the company’s imports several times in October 2014.
• American Family Pharmacy recalled Assured Aspirin Enteric Safety Coated Tablets because the product failed to meet specifications on assay, content uniformity, and dissolution.
• Forest Pharmaceuticals recalled a professional sample of Bystolic (nebivolol), a beta blocker that treats high blood pressure. The 20 mg/tablets are packaged as 7 tablets/bottle, and 12 bottles/trays. The product was recalled due to failed dissolution specifications at the 6-month stability time point.
• Hospira recalled Hydromorphone Hydrochloride Injection, due to the lack of sterility as a customer complained of broken or cracked container vials.
• Zee Medical Products recalled ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.

Classification III Drug Recall

A Classification III recall signifies that the product is not likely to cause adverse health consequences.

American Health Packaging of Columbus, OH recalled MethylPREDNISolone tablets due to subpotency at the 6-month stability time point.