FDA Enforcement Report Included Compounded Drugs in Classification I and II

Weekly FDA Enforcement Report For Drugs 9/3/14

By Cyndi Root

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for September 3, 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 recalled Mineral IV Injection due to non-sterility concerns, as analytical results found the product to contain Sphingomonas paucimobilis. The Centers for Disease Control (CDC) says that these types of product impurities occur more often to compounding pharmacies than to pharmaceutical manufacturers due to less stringent regulations.
• Pharmakon Pharmaceuticals recalled Midazolam HCl 1 and 2 mg/ml because the product contained undeclared benzyl alcohol. The company also recalled Atropine Sulfate due to the same reason.
• Central Admixture Pharmacy Services recalled Pediatric Cardioplegia, del Nido Cardioplegia with Lidocaine, Adenosine, and Low Potassium Cardioplegia due to non-sterility from a microbial contamination identified as the Aspergillus species. The fungi is known to play a role in opportunistic infections, allergies, and toxicities.

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

• Abrams Royal Pharmacy recalled all of its sterile products compounded at its pharmacy in Dallas, TX due to sterility concerns.
• Alkermes recalled Vivitrol (naltrexone for extended-release injectable suspension) because customers complained that it failed to deliver the dose.
• Pharmakon Pharmaceuticals recalled Glycopyrrolate because of the presence of benzyl alcohol. This company also had three Class I recalls due to benzyl alcohol.

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

• Mylan Pharmaceuticals recalled Diltiazem HCl because routine stability testing showed impurities and out-of–specification results. 
• Novel Laboratories recalled Famotidine for Oral Suspension because it failed 12-month stability testing. The medication treats stomach and intestinal disorders such as ulcers, Zollinger-Ellison syndrome, erosive esophagitis, and gastroesophageal reflux disease (GERD). 
• Perrigo Holland recalled Nicotine Polacrilex Lozenges due to failed dissolution specifications and the presence of broken lozenges.

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