Weekly FDA Enforcement Report For Drugs 11/26/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for November 26, 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.

• Abrams Royal Pharmacy in Dallas, TX issued product recalls on Calcium Chloride Preservative Free Sterile injection (100 mg/ml, 10 ml vial), Lidocaine/Bupivacaine/Epinephrine/Hyaluronidase (in 11 mL sterile syringes), and Trace Mineral-5 MDV (in 10 mL vials). The company enacted the recalls when its contract laboratory identified sterility concerns and found Staphylococcus warneri in the product. The pathogen is commonly found in the epithelia and mucosal membranes of humans. It is capable of causing infection, even in the immunocompetent. S. warneri also exhibits antibiotic resistance.

Classification II Drug Recall

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

• Prometheus Laboratories from San Diego, CA recalled Mercaptopurine Tablets in 50- and 250-count bottles. The prescription only product is manufactured by Stason Pharmaceuticals from Irvine, CA. The nationwide recall included over 20,000 bottles and was due to failed dissolution specifications as the product was found to be Out Of Specification (OOS) during stability testing.
• Micro Labs from Princeton, NJ recalled Losartan Potassium tablets in 1000-tablet bottles. The product is manufactured in India. The recall was due to failed Content Uniformity Specifications as the dry mix failed to blend uniformly.
• Spectrum Laboratory Products from Gardena, CA recalled Tetrahydrozoline Hydrochloride manufactured by Spectrum Chemical, also from Gardena, CA. The voluntary nationwide recall was due to CGMP deviations as the product was stored or dispensed in a non-GMP compliant warehouse, the S.I.M.S. facility in Italy.

Classification III Drug Recall

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

Hospira issued a nationwide recall for Vancomycin Hydrochloride for Injection, a sterile powder in vials, packaged in 10-count trays. The recall of approximately 300,000 vials was due to incorrectly labeled product trays identifying the product as another product.