Weekly FDA Enforcement Report For Drugs 10/22/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 15, 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.

• Hospira initiated a nationwide recall of Lidocaine HCl Injection, for prescription only. The local anesthetic that reduces pain was recalled due to the presence of particulate matter. The product was discolored and contained visible particulates of iron oxide in the solution and embedded in the glass vial. Hospira has recalled this product previously and the FDA issued a press release in July 2014, stating the risk factors associated with the compromised product, including the risk of injecting the particulate matter. Symptoms of injected iron oxide could include inflammation, mechanical disruption of tissue, or immune response to the particulate.

Classification II Drug Recall

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

• Unit Dose Solutions of Morrisville, NC issued a recall to Pennsylvania for Atorvastatin Calcium 40 mg tablets. The agent, which is a bioequivalent to Lipitor, was recalled because the tablets were packaged with Valacyclovir HCl tablets.
• Gyma Laboratories of Westbury, NY recalled Dipyridamole API, made in Italy. The company received notice that the Italian Medicines Agency observed cGMP deviations. Gyma also recalled Propranolol HCl, Clonidine Base Micronized, and Clonidine HCL for the same reason.
• Zydus recalled Topiramate tablets, an epileptic seizure medication, manufactured by Cadila Healthcare from Ahmedabad, India. The nationwide recall was due to the comingling of 100 mg tablets with 200 mg tablets.
• Avella of Deer Valley recalled Hydroxyprogesterone Caproate due to crystal formations in the product.
• Sagent recalled Ketorolac Tromethamine injection from the U.S. and Puerto Rico because the label contained an incorrect expiration date.

Classification III Drug Recall

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

• Valeant recalled Vasotec (enalapril maleate) tablets because the package insert was incorrect. The company also recalled Hydrocortisone Butyrate Cream and Locoid (hydrocortisone butyrate 0.1%) due to subpotency at the 18-month stability test point.