Tuesday, July 22, 2014

Weekly FDA Enforcement Report For Drugs And Biologics 7/16/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for July 16, 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: No Class I drugs recalled this week.
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.
  • DrugsUnited Therapeutics from Research Triangle Park, NC voluntarily recalled Tyvaso (treprostinil)Oral Inhalation Solution due to incorrectly installed software that may cause the drug delivery device to be inoperative. Fresenius Kabi of Melrose Park, IL recalled Fosphenytoin Sodium Injection for prescription due to glass vial delamination and glass particulates in the vials. Healix Infusion Therapy from Sugarland, TX voluntarily issued a letter to Texas recalling BUPivacaine HCl due to a customer complaint of visible particles embedded in the glass vial. Boehringer Ingelheim Roxane recalled Calcitriol Oral Solution for prescription only due to degradation at the nine-month stability time point. Teva recalled Fluvastatin Capsules because of a customer complaint trend regarding capsule breakage. Hospira recalled Heparin Sodium in 5% Dextrose Injection due to a confirmed consumer report of fluid leaking from primary container.
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: One Class III drug was recalled this week. Ferring Pharmaceuticals voluntarily recalledEndometrin (progesterone) Vaginal Insert 100 mg USP, for prescription only, by issuing a letter nationwide. The recall was due to discoloration from prolonged heat exposure. The drug helps women achieve pregnancy and birth.
openFDA and Recalls
In the Food and Drug Administration’s new openFDA program, the agency has provided developers and researchers with a Programming Interface (API) to allow direct access to all of the enforcement reports dating back to 2004. In a recent FDA Voice article, Taha A. Kass-Hout, the FDA Chief Health Informatics Officer and Director of FDA Office of Informatics and Technology Innovation, said, “It’s also important to note that this API, like all others on openFDA, are in beta and are not ready for clinical use. However, their contribution to FDA’s public health mission already now grows every day.”

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