Weekly FDA Enforcement Report For Drugs 8/20/14

The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 13, 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. 

Classification I Drug Recall

A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.

• Sung Soo Kim from Los Angeles, CA voluntarily recalled Super ARTHGOLD manufactured for and distributed by Nanowellbeing Health from La Mirada, CA. The nationwide recall is due to marketing without an approved NDA/ANDA as the product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
• Bacai dba Ky Duyen House from Fountain Valley, CA recalled Lite Fit USA due to the presence of sibutramine, making it an unapproved new drug. The presence of sibutramine is a common reason for recalls. Abbot withdrew the obesity drug from the market in the U.S. due to clinical trial data indicating an increased risk of heart attack and stroke.

Classification II Drug Recall

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

• Teva recalled Carbidopa and Levodopa tablets manufactured in Israel for prescription only, due to the potential for super-potent tablets. The combination medication is used to treat Parkinson's disease and Parkinson's-like symptoms that may develop after injury to the nervous system or brain caused by carbon monoxide poisoning or manganese poisoning.

Classification III Drug Recall

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

• Bracco Diagnostic from Monroe Township, NJ recalled E-Z-HD (barium sulfate) for suspension manufactured by E-Z-EM Canada from Lake Success, NY. The recall is extended nationwide and Puerto Rico due to sub-potency as low specification results were obtained for both pH and assay during routine stability testing after 36 months.
• Pfizer recalled Depo-Medrol (methylprednisolone acetate injectable suspension USP) distributed by Pharmacia & Upjohn, a division of Pfizer. The voluntary nationwide recall was due to a failed pH specification of 2.9 at the 9-month stability test interval, where the registered specification for pH is 3.0 - 7.0.