Weekly FDA Enforcement Report For Drugs 11/12/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for November 12, 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.

• Oregon Compounding Centers dba Creative Compounds dominated the Class II recalls this week with over 40 products recalled. During a recent FDA inspection, quality control procedures were lacking leading to a loss of confidence in the sterility of the products. In October 2014, the FDA issued a press release stating that the company’s products were being recalled due to sterility concerns.
• Sun Pharma Global recalled Venlafaxine Hydrochloride ER due to failed dissolution specifications at 12 months.
• Pharmaceutical Associates recalled Cyproheptadine HCl Syrup because of an unidentified impurity at the 12-month stability test point.
• Physicians Total Care recalled Cephalexin Monohydrate capsules manufactured by Sun Pharmaceuticals due to CGMP deviations. The products were manufactured with active pharmaceutical ingredients that were not produced in accordance with good manufacturing practices.

Classification III Drug Recall

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

• Pfizer recalled Torisel Kit (temsirolimus) injection, distributed by Wyeth Pharmaceuticals. The agent is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. The recall is due to crystallization caused by impurities in a raw material used to manufacture the diluent.
• Physicians Total Care recalled Loratadine, an over-the-counter (OTC) antihistamine used to treat the symptoms of hay fever, which is manufactured by Novartis. The recall was due to chipped or broken tablets in some lots.

Nanophase Technologies recalled Z-COTE, Zinc Oxide and Triethoxycaprylylsilane powder because the incorrect amount of a raw material was added during the manufacturing process.