Weekly FDA Enforcement Report For Drugs 12/02/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for December 2, 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 drug recalls this week.

Classification II Drug Recall

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

• Hospira recalled several Class II drugs this week, including Normosol-R pH 7.4 Multiple Electrolytes Injection, Lactated Ringer's, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Sterile Water for Injection. The nationwide recalls were also issued in Puerto Rico and the U.S. Virgin Islands. All of the recalls were due to the lack of assurance of sterility as the primary bags and overwrap are vulnerable to puncture and leakage.

Hospira stated in a letter to a pharmacy director that its bags were made from polyvinyl chloride (PVC) or thermoplastic copolyester (CR3) and were permeable to moisture. The overwrap bag is intended to delay the solution’s evaporation, resulting concentration of the agent, and out-of-specification result.

• Actavis recalled Diclofenac Sodium and Misoprostol Delayed-Release tablets manufactured by Watson Laboratories from Corona, CA. The company issued the recall due to the presence of split or broken tablets.
• Baxter recalled Potassium Chloride Injection because of a labeling error and Heparin Sodium in 0.9% Sodium Chloride Injection due to subpotency.
• Perry Drug recalled Testosterone CYP-250/PROP-20 mg, 10 ml Syringe, Methyl B12 25 mg/mL Inj., 10 Syringes, Tri-Mix (PGE-10MCG/PAP-30MG/PT 5 ml vials, and several other agents. During a recent FDA inspection, investigators found quality control procedures that risked sterility. The FDA issued notice to the company in September 2014, making several observations on sterile conditions.

Classification III Drug Recall

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

Zydus Pharmaceuticals from Pennington, NJ recalled Amlodipine Besylate tablets manufactured by Cadila Healthcare from Ahmedabad, India. The company issued the nationwide recall due to brown or discolored tablets. The agent is a channel blocker used in the treatment of hypertension.