Weekly FDA Enforcement Report For Drugs And Biologics 5/28/14
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 28, 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.
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
- Biologics: No Class I biologics recalled this week.
- Drugs: Herbal Give Care LLC recalled several varieties of its Esbelin and Esbelder products due to undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine, illegal additives for weight loss. Tendex recalled P-BOOST and NATURECT due to undeclared tadalafil, a drug used to treat erectile dysfunction. Schindele Enterprises dba Midwest Wholesale recalled XZONE GOLD, BOOST ULTRA, SEXY MONKEY, MiracleZEN Platinum, Magic For Men, ExtenZe, and XZEN PLATINUM because of undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. The Human Science Foundation recalled PRO ArthMax due to the presence of several undeclared drugs. Pfizer recalled Effexor XR (venlafaxine HCl) due to a mix-up with Tikosyn (dofetilide) capsules.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: Blood Systems, Talecris Plasma Resources, the American National Red Cross, Plasma Biological Services, LifeSouth Community Blood Centers, Minnesota Lions Eye Bank, DCI Biologicals, Orlando LLC, Blood Assurance, and HCSC-Blood Center recalled various biological products including plasma, red blood cells, and platelets. Most were recalled due to unsuitable donors.
- Drugs: Teva Pharmaceuticals USA recalled Indomethacin, Buprenorphine Hydrochloride, and QVAR (beclomethasone dipropionate HFA) because of CGMP deviations, impurities, and defective delivery. Fresenius Medical Care Holdings recalled phosLo (calcium acetate) due to cross-contamination. SigmaPharm Laboratories recalled Liothyronine Sodium tablets. Forest Pharmaceuticals recalled Bystolic (nebivolol). Zydus Pharmaceuticals USA recalled Promethazine Hydrochloride.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: OneBlood recalled Red Blood Cells Leukocytes Reduced. Arc Blood Services, New England Region recalled Cryoprecipitated AHF, Pooled. International Sight Restoration and DCI Donor Services dba Sierra Donor Services recalled human corneas. Gen-Probe recalled Human Immunodeficiency Virus Type 1 and/or HCV and/or HBV (Nucleic Acid Pooled Testing/Syn).
- Drugs: Oasis Medical recalled Oasis TEARS, Lubricant Eye Drops, due to a missing label.