Weekly FDA Enforcement Report For Drugs 10/1/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 1, 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 recalls this week.

Classification II Drug Recall

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

• Baxter issued a voluntary nationwide recall for Potassium Chloride Injection in sterile bags for prescription only. The recall occurred because the product actually contains Gentamicin Sulfate. Potassium chloride injection is a parenteral fluid and electrolyte replenishment, utilized when oral replacement is not feasible. Gentamicin sulfate is an antibiotic commonly used to treat serious bacterial infections.
• Alvogen from Pine Brook, NJ recalled Oxycodone and Acetaminophen tablets manufactured by Norwich Pharmaceuticals of Norwich, NY. The nationwide recall was due to the failure of the oxycodone component to meet acceptance criteria for uniformity of dose. 
• Hospira recalled Buprenorphine Hydrochloride Injection for intramuscular or intravenous use, available by prescription only. The opioid analgesic was recalled because the product failed its 9-month stability testing with out of specification results for pseudobuprenorphine impurity. In a September 9, 2014 recall for the same product, Hospira issued a letter to customers, informing them that the pseudobuprenorphine impurity is a known issue with buprenorphine formulations, and administration may cause anaphylaxis, nausea, dizziness, respiratory depression, or coma.
• Noven Pharmaceuticals from Miami, FL recalled Daytrana (methylphenidate transdermal system) patch. The medication for Attention Deficit Hyperactivity Disorder (ADHD) was out of specification for mechanical peel force (MPF), giving patients and caregivers difficulty in removing the patch from the liner. 

Classification III Drug Recall

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

• Akorn from Lake Forest, IL recalled Rifampin for Injection for IV Infusion only, due to impurities at the 22-month stability time point.
• Apotex recalled Olanzapine Orally Disintegrating Tablets because of sub-potency at the 9-month temperature point.
• Qualitest Pharmaceuticals from Huntsville, AL recalled Methylprednisolone tablets due to sub-potency at the 6-month stability time point.