Weekly FDA Enforcement Report For Drugs 8/27/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 27, 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.

• Hospira recalled DOBUTamine Injection in a Single-dose Flip-top Vial, for prescription only, due to glass particulates in a discolored solution. The company from Lake Forest, IL also recalled Propofol Injectable Emulsion for I.V. administration because of a glass defect and visible metallic particulates found in the solution.
• Baxter Healthcare recalled 0.9 % Sodium Chloride Injection in a VIAFLEX plastic container due to blue polyisoprene shavings found inside the bag port tubes.
• Pharmacy Creations from Randolph, NJ recalled prescription-only Ascorbic Acid due to mold contamination.

Classification II Drug Recall

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

• U.S. Compounding recalled ePHEDrine Sulfate Injection due to a labeling error, as the outer protective bags were mislabeled.
• Doctor's Best recalled Red Yeast Rice because an FDA analysis showed undeclared lovastatin, making the product an unapproved new drug. Lovastatin is a HMG CoA reductase inhibitor (statin), used for lowering cholesterol. 
• Ben Venue Laboratories recalled CYTARAbine for Injection due to sterility concerns as crimp defects could affect the container’s closure integrity.
• Fresenius Kabi USA recalled Propranolol Hydrochloride Injection because the Italian Medicines Agency (AIFA), cited its API supplier for deficiencies.
• Wockhardt USA recalled Metoprolol Succinate due to failed dissolution specifications.
• Baxter recalled ProSol Injection due to the presence of particulates identified as organic material and the amino acid leucine.  
• Healix Infusion Therapy recalled five strengths of Fentanyl due to flip-top vial crimps that were loose or missing, causing a lack of sterility.

Classification III Drug Recall

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

• Mylan Pharmaceuticals recalled Tolterodine Tartrate Tablets because the product showed impurities and degradation.
• Trigen Laboratories recalled Triveen-PRx RNF capsules because the label indicates that the product contains Vitamin B12, but the formulation of this product does not contain Vitamin B12.