News Feature | February 19, 2014

Weekly FDA Enforcement Report For Drugs And Biologics

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By Cyndi Root

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 12, 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. Recalls can be viewed by Biologics or Drugs, and by Classification, the danger level. 

Classification I Recall

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

  • Biologics: No biologics recalled this week.
  • Drugs: B. Braun Medical Inc. of Irvine, CA has voluntarily issued a nationwide recall for Cefepime Injection USP and Dextrose Injection USP. It comes in duplex container, 1 g in 50 mL, for prescription IV use only. It was recalled due to the presence of visually detectable organic particulate. Baxter Healthcare Corp. issued a nationwide recall and to Saudi Arabia and Colombia for 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers. The product was recalled due to particulate, identified as rubber.

Classification II Recall

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

  • Biologics: Several firms recalled Class II biologics this week. OneBlood, Inc. recalled cryoprecipitated AHF, platelets, and red blood cells due to uncertainty about the donor’s suitability. OneBlood, doing business as CBCF, recalled plasma, red blood cells, and platelets due to donor suitability. Blood Systems Inc. recalled Platelets Pheresis Leukocytes Reduced due to insufficient plasma to support the platelet concentration.
  • Drugs: Insight Instruments, Inc. recalled Cornea Coat, Hydroxypropylmethylcellulose due to lack of FDA approval. Health & Beyond marketed a dietary supplement without approval and it contained Doxepin and Chlorpromazine, an antidepressant and an antipsychotic. Faria Limited LLC dba Sheffield Pharmaceuticals recalled Dr. Sheffield Triple Antibiotic Ointment due to the presence of gram-positive microbes. Several other Class II drugs were recalled this week.

Classification III Recall

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

  • Biologics: Medic Inc. recalled blood and plasma due to extended expiration dates.
  • Drugs: Forest Pharmaceuticals Inc. of Earth City, MO recalled three variations of Namenda XR (memantine HCl): capsule, titration pack, and sample pack. Pfizer recalled Glucotrol XL. Greenstone LLC recalled Glipizide XL.

About FDA Enforcement Reports

Users have several options in viewing the report. The Product view is set as default. Users can select Event View, Print-Friendly View, Pending, and Download CSV.  Sort information by Reason for Recall, Classification, Code, and Recalling Firm. Choose More Info for additional details and select Pending for recalls in the process of being classified. For more information, view the Enforcement Report Navigation and Definitions page.

Sources:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=02122014&lang=eng#biologics

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=02122014&lang=eng#drugs