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FDA MedWatch - Cefazolin for Injection Recalled Due to Microbial Contamination of Active Ingredient
BETHESDA, M.D. -- March 2, 2006 -- Hanford Pharmaceuticals and the United States Food and Drug Administration (FDA) notified healthcare professionals about the recall of four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment to treat skin and skin structure, respiratory and other infections.
The product was distributed by Sandoz, Inc. of Broomfield, Colorado, and Watson Pharmaceuticals, Inc. of Corona, California.
Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus) which may pose a serious or life-threatening risk for some patients. Hospitals, clinics, and users should stop using the affected lots immediately.
SOURCE: The FDA Safety Information and Adverse Event Reporting Program
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