Weekly FDA Enforcement Report For Drugs And Biologics 5/21/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 21, 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: Pain Free By Nature from Harper, KS issued a voluntary nationwide recall including Puerto Rico for Reumofan Plus Tablets. The product contains undeclared diclofenac and methocarbamol, a nonsteroidal anti-inflammatory drug (NSAID) for inflammation and pain, and a muscle relaxant, respectively.

The FDA issued a press release in March warning the public about undeclared drugs in Reumofan. The Reumofan product is a treatment for painful conditions like osteoporosis and bone cancer. Pain Free By Nature distributes it through internet sales. The FDA has been recalling this product since 2012, warning consumers about the dangers, “increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, fatal perforation (causing a hole), sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.”

Classification II Recall

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

• Biologics: No Class II biologics recalled this week.
• Drugs: Teva Pharmaceuticals USA recalled four products this week due to CGMP laboratory testing deviations: Glyburide and Metformin Hydrochloride tablets, Indomethacin capsules (25 and 50 mg), and Methyldopa tablets. First Aid Only Inc. recalled Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes because they contain aspirin and not ibuprofen. Due to improper marketing claims. Flawless Beauty LLC recalled Laroscorbine Platinium (vitamin C/collagen) injectable I.V., Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, Saluta (reduced glutathione) Powder for Injection, Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, Vitamin C (ascorbic acid) Injection, and Sterile Water for Injection.  

Classification III Recall

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

• Biologics: No Class III biologics recalled this week.
• Drugs:  Konsyl Pharmaceuticals Inc. from Easton, MD recalled Psyllium Fiber, Laxative/Supplement because of a labeling error, as the listed active ingredient strength is inaccurate.