Weekly FDA Enforcement Report For Drugs And Biologics 4/30/14
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 30, 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 were recalled this week.
- Drugs: Dolphin Intertrade Corporation recalled JaDera and Xiyouji Qingzhi due to undeclared Sibutramine, which means it was marketed without an approved NDA/ANDA. Fossil Fuel Products recalled RezzRX capsules due to undeclared hydroxythiohomosildenafil and amino-tadalafil. The FDA previously alerted the public in 2013 about this company and product containing sexual enhancement drugs. Brookfield Prescription Center recalled Glycopyrrolate (MDV) 0.2 MG/ML Injectable due to contamination with Bacillus thuringiensis. Shire Human Genetic Therapies, Inc. recalled VPRIV (velaglucerase alfa for injection) due to stainless steel and barium sulfate particulates.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: 15 blood centers across the country recalled biological products. Products include Platelets Pheresis Leukocytes Reduced, Red Blood Cells, Platelets, and Plasma. Reasons for recalls include unsuitable donors and incorrect storage
- Drugs: Pfizer recalled Tikosyn (dofetilide) due to a mix-up in prescription strength; a 250 mcg capsule was discovered in a 500 mcg bottle. Ohm Laboratories recalled Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant Pseudoephedrine Sulfate because of defective packaging.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: Eight blood centers recalled eight Class III biological products this week. A blood product did not meet the minimum requirement for Red Blood Cell recovery; there were anticoagulant labeling inaccuracies; the entire amount of additive solution was not added during manufacturing; and there was collection from a donor without body temperature documentation.
- Drugs: GlaxoSmithKline recalled several varieties of its nicotine replacement products due to failed Lozenge Specifications; lozenges are overly thick, overly soft, and sub and superpotent. P&L Developments recalled Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl due to subpotency. Upsher Smith Laboratories recalled Oxandrolone Tablets because of missing labels.