Hanford Pharmaceuticals Issues a Nationwide Recall of Cefazolin for Injection Because of Possible Health Risk

The Food and Drug Administration (FDA) released the following information:

Contact:
G.C. Hanford Manufacturing Co.
315-476-7418

Hanford Pharmaceuticals Inc., of Syracuse, NY, is voluntarily recalling four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment.  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.  Cefazolin for Injection, USP is used to treat skin and skin structure, respiratory and other infections.

The firm is notifying its customers and users of the recall by letter, and asking that they stop distribution, recall from their accounts, and request the return of the recalled lots. Hospitals, clinics, and users should stop using the affected lots immediately. The letter advises that the product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Check the lot numbers on the product label and promptly return any with the following lot numbers:  Sandoz product - C4650, C4537; Watson product - C4689, C4665.

Patients who feel that they may have experienced an adverse reaction to recalled product should seek medical help.  Patients or users can contact the firm at (315)  476-7418. 

To date, the firm has not received any confirmed reports of adverse events or complaints related to the recalled lots.

Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.