Weekly FDA Enforcement Report For Drugs 12/17/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for December 17, 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, the danger level.

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.

• Fresenius Kabi recalled several Class II products this week. Midazolam Hydrochloride Injection, Ondansetron Injection, and Cyanocolbalamin Injection were recalled as they may contain glass particles and fractures. Gentamicin Injection in a multiple dose vial was recalled because some vials may be missing a stopper. The recall of the Gentamicin Injection did not come at a good time due to the ongoing shortage of the drug. In November, Hospira discontinued its supply of the agent used as an antibiotic for infections.
• Baxter recalled Famotidine Injection in a single dose container because of the presence of particulate matter. A person complained of plastic or rubber in the pre-mixed container. Famotidine is used to decrease stomach acid in patients with ulcers and other conditions.
• Pfizer recalled Tikosyn (dofetilide) in 14-count and 60-count bottles due to cracked or broken capsules. The agent is an antiarrhythmic used to restore normal heart rhythms in patients with atrial fibrillation or atrial flutter.
• Hospira recalled Fentanyl Citrate Injection in flip-top vials, 25 units per box, 50 units per case. The nationwide recall was due to the lack of assurance of sterility as the vials were improperly crimped.

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

• CareFusion 213 from El Paso, TX recalled Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub. The recall was issued nationwide and to Mexico and the Philippines. The firm-initiated recall was due to high concentrations of chlorhexidine gluconate.
• Sandoz recalled Fluoxetine capsules in Arizona due to a labeling error on a capsule; the logo was illegible.