Weekly FDA Enforcement Report For Drugs 9/24/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for September 24, 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.

• Nova Products from Aston, PA recalled eight Class I products. The firm issued a voluntary nationwide recall of African Black Ant, Black Ant, Xzen, Xzen Gold, Xzen Platinum, Xzone, Xzone Gold, and Mojo Rising. The company recalled the products because an FDA laboratory analysis revealed sildenafil, an active ingredient of FDA-approved drugs used to treat erectile dysfunction. The FDA issued a press release in April 2014 announcing a recall of the same set of drugs, saying that the undeclared active ingredients pose a threat to consumers because they can interact with nitrates found in some prescription drugs and possibly cause a decrease in blood pressure.
• Bristol-Myers Squibb recalled Coumadin for Injection (Warfarin Sodium for Injection) due to the presence of particulate matter in vials that was identified as metallic-like and non-metallic cellulose fiber particles.
• Nature’s Universe from Nashville, TN recalled Thinogenics due to undeclared sibutramine.
• Baxter recalled Sodium Chloride Injection and Potassium Chloride Injection due to the presence of particulates identified as fiber or plastic.
• American Health Packaging recalled Ibuprofen Tablets and Oxcarbazepine Tablets due to labeling mix-ups.

Classification II Drug Recall

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

• Unique Pharmaceutical recalled Norepinephrine 4 mg in 250 mL/Sodium Chloride 0.9% because of the lack of assurance of sterility, as a mold-like substance was discovered on the surface of an unopened bag.
• Solace International recalled Dermatend mole, wart, and skin tag remover because the product is not FDA approved and the labeling contains unproven claims of safety and efficacy.
• Hospira recalled Bupivacaine HCl Injection because a customer complained of brown, rust-colored particles embedded at the bottom of the glass vial.

Classification III Drug Recall

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

• Taro Pharmaceuticals recalled Warfarin Sodium Tablets due to failed content and uniformity specifications.
• Apotex recalled Candesartan Cilexetil and Hydrochlorothiazide tablets because the product was out of specification for CAD II degradant.