Monday, March 17, 2014

Weekly FDA Enforcement Report For Drugs And Biologics

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for March 12, 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 Biologics or Drugs, and by Classification, the danger level. 
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
  • Biologics: No biologics recalled this week.
  • Drugs: Three Class I drugs were recalled this week, from the same company Mira Health Products Ltd. from Farmingdale, NY. The company recalled B-50 capsules, Super-DMZ Rx 2.0 Capsules, and METHA-DROL Extreme capsules. The products were marketed without approval and found to contain steroids and/or steroid-like drug ingredients. The FDA issued a press release a year ago about the company’s unapproved products.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
  • Biologics: There were several Class II biologic recalls this week. They include products from The American National Red Cross South Carolina Region, Blood Systems, and OneBlood. Recalled products include Platelets Pheresis Leukocytes Reduced, Red Blood Cells Leukocytes Reduced, Cryoprecipitated AHF, and Source Plasma. Reasons for recalls include improper pH testing and unsuitable donors.
  • Drugs: There were a number of Class II drug recalls this week. Natures Pharmacy & Compounding Center from Asheville, NC accounted for most of them. Lidocaine 4% Urethral Gel, Bleomycin Sulfate 1unit/ml, Dexamethasone (pf) 0.05 %, and Folic acid (pf) 10mg/cc and others were recalled due to lack of sterility observed during a recent inspection. Teva Pharmaceuticals from Horsham, PA recalled a few products including Teva Ethambutol Hydrochloride Tablets and Teva Hydroxyzine Pamoate Capsules due to deviations in the manufacturing process.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
  • Biologics: Blood Systems, Inc. recalled Red Blood Cells Leukocytes due to an ineligible donor.
  • Drugs: Aaron Industries Inc. of Lynwood, CA recalled Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) due to precipitate in the product.
About FDA Enforcement Reports
Users have several options in viewing the report. The Product view is set as default. Users can select Event View, Print-Friendly View, Pending, and Download CSV.  Sort information by Reason for Recall, Classification, Code, and Recalling Firm. Choose More Info for additional details and select Pending for recalls in the process of being classified. For more information, view the Enforcement Report Navigation and Definitions page.

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