Weekly FDA Enforcement Report For Drugs 10/15/14

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.

• Unique Pharmaceutical from Temple, TX issued a nationwide recall for N-Acetyl Cysteine 20 percent, 4 mL vial. The recall was due to non-sterility, as one lot of the vials tested positive for Herbaspirillum huttiense, a gram-negative species of bacteria. The agent is for treatment of abnormal, viscid, or inspissated mucous secretions common in conditions such as emphysema, and bronchitis, and from pulmonary complications associated with surgery and post-traumatic chest conditions, among others.

Classification II Drug Recall

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

• Mylan recalled Metoprolol Succinate extended-release tablets because a pharmacist noticed a rogue tablet of a different size and markings in a bottle of Metoprolol.
• Unique Pharmaceutical recalled all sterile products because an FDA inspection revealed poor aseptic production practices.
• Zydus Pharmaceuticals recalled ZyGenerics Atenolol tablets manufactured by Cadila Healthcare of Ahmedabad, India. Zydus issued a nationwide recall because a pharmacist reported superpotency and tablets that were noticeably thicker in appearance.
• Astellas recalled Tarceva (erlotinib) tablets manufactured by Kremers Urban Pharmaceuticals from Seymour, IN. The product did not pass the acceptance criteria for the dissolution test during the 24-month routine stability testing.
• VistaPharm recalled Metoclopramide Oral Solution due to a defective container, which leaks.
• Janssen Ortho recalled Xarelto (rivaroxaban) because a consumer complained of microbial contamination.
• Mckesson from Jacksonville, FL recalled Amiodarone HCl Injection, an antiarrhythmic drug, because one shipment was refrigerated instead of being stored at room temperature.

Classification III Drug Recall

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

• Bracco Diagnostic from Monroe Township, NJ recalled E-Z-GAS II Effervescent Granules Antacid/Antiflatulent due to subpotency during routine stability testing at 24 months.
• Gilead recalled Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets due to the presence of small red silicone rubber particulates. Truvada is a medication to prevent and treat HIV-1.