Weekly FDA Enforcement Report For Drugs 10/7/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 7, 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.

• Eugene Oregon from Levittown, PA recalled Black Ant, Mojo Risen, and African Black Ant, manufactured by Qinghai Baojiantang Pharmaceutical, located in China. The recalls are due to undeclared sildenafil (Viagra), which makes the product marketed without an approved NDA/ANDA. The company issued at least two recalls this year for the same issue.
• Hospira recalled Marcaine (bupivacaine HCl) injection because of a confirmed customer complaint of visible metal particles in the glass vial and the solution.
• Cubist Pharmaceutical from Lexington, MA issued a nationwide recall and recalls to Israel and Taiwan for Cubicin (daptomycin for injection), an antibacterial used to treat complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia). The voluntary recall was due to glass particulate matter in the vials.
• Baxter recalled Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution due to particulate matter that was found in the manufacturing process.

Classification II Drug Recall

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

• New England Home Therapies recalled all sterile drugs compounded between 2/21/14 and 2/24/14 due to a lack of sterility assurance. The company is a subsidiary of BioScrip and provides products for heart failure, hemophilia, and oncology, among others.
• Sagent Pharmaceuticals recalled Zoledronic Acid Injection because the bags were leaking.
• Actavis recalled Diclofenac Sodium and Misoprostol Delayed-Release tablets because the tablets were split or broken.
• AbbVie recalled Creon (pancrelipase) Delayed-Release capsules because LipaCreon 13000 was co-mingled in the product.
• Baxter recalled Dopamine Hydrochloride and 5 percent Dextrose injection because of a small cut in the solution bag, resulting in a leak of the bag into the over-pouch.

Classification III Drug Recall

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

No Class III recalls this week.