Weekly FDA Enforcement Report For Drugs And Biologics 6/4/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 4, 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: Deseo Rebajar from Fajardo, Puerto Rico recalled Burn 7 Capsules, supplied in 30 capsule bottles due to undeclared sibutramine, an appetite suppressant, and phenolphthalein, a laxative, in the dietary supplement. The FDA declared that phenolphthalein was not safe and effective in 1999 and withdrew sibutramine from the market in 2010 due to serious cardiovascular risks.

The FDA issued a press release in December of 2013 regarding the same product, recalling Burn 7 capsules and warning the public about the threat to those with coronary artery disease, congestive heart failure, arrhythmias, or stroke. In April 2014, the FDA sent a warning letter to the company, which stated that a review of Deseo Rebajar’s website showed that the products Adipotrim XT, Burn 7, Reductrol Fat Burner Formula, Adipocleanse, Adipocleanse XT, Lipozene, and Slim Patch are unapproved new drugs.

Classification II Recall

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

• Biologics: LifeShare Blood Centers from Shreveport, LA voluntarily recalled Platelets Pheresis Leukocytes Reduced due to insufficient quality control. The company also recalled Red Blood Cells Leukocytes Reduced because of a donor that travelled to a malaria epidemic area. Central California Blood Center from Fresno, CA recalled Platelets Pheresis Leukocytes Reduced, Platelets Pheresis Leukocytes Reduced Irradiated, and Platelets Pheresis Leukocytes Reduced due to quality control issues and platelet units that failed residual white blood cell counts.
• Drugs: Teva Pharmaceuticals USA from Horsham, PA recalled ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, due to a failed sterility test. Sandoz, Inc. recalled Cefpodoxime Proxetil Tablets because of the presence of stainless steel particulates. Wockhardt USA Inc. recalled Metoprolol Succinate Extended-Release Tablets due to a failed dissolution test.

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: Prestige Brands Holdings recalled PediaCare Nighttime Multi-Symptom Cold and PediaCare Day & Night Value Pack due to a small amount of diphenydramine that precipitated out of the solution.