Weekly FDA Enforcement Report For Drugs And Biologics 6/18/14
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 18, 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: MyNicNaxs recalled Fruta Planta, Jianfeijindan Activity Girl, Fruta BIO, Super Fat Burning Bomb, SlimEasy Herbs, Meizi Evolution, Slim Xtreme, Magic Slim, and Meizitang due to unauthorized marketing and the presence of N-desmethylsibutramine, benzylsibutramine, and sibutramine. Vitality Research Labs recalled vitaliKOR Ready When You Are because of undeclared vardenafil and tadalafil. Greenstone recalled Venlafaxine. Pure Edge Nutrition recalled several Bella Vi products due to undeclared sibutramine and phenolphthalein. Pharmakon Pharmaceuticals recalled Midazolam due to superpotency. Cubist recalled Cubicin because of a glass shard in a vial.
N-desmethylsibutramine, benzylsibutramine, sibutramine, vardenafil, tadalafil, and phenolphthalein are agents that are commonly used to adulterate medicines. The FDA addressed this issue this year saying that the consequences of counterfeiting and adulteration are tragic. Counterfeit drugs are often processed under unsanitary and poorly controlled conditions and their safety and effectiveness is unknown.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: Talecris Plasma Resources recalled plasma. The HCSC-Blood Center recalled Platelets, Red Blood Cells, and Plasma due to donor unsuitability. The Blood Center of Wisconsin recalled red blood cells because of failed post-filtration acceptance criteria. Carter BloodCare recalled Red Blood Cells (Apheresis) Leukocytes Reduced due to donor unsuitability. LifeShare Blood Centers recalled Red Blood Cells Leukocytes Reduced because a donor travelled to a malaria area.
- Drugs: Legacy Pharmaceutical recalled Pantoprazole Sodium due to mislabeling. Dr. Reddy's Laboratories recalled Metoprolol Succinate because of a failed dissolution test.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: LifeShare Blood Centers of Monroe, LA recalled blood products due to an incomplete donor history.
- Drugs: No Class III drugs recalled this week.