FDA and Hanford Pharmaceuticals Announce Nationwide Recall of Injectable Cefazolin for Potentially Life-Threatening Bacterial Contamination

Hanford Pharmaceuticals Inc., of Syracuse, New York, is voluntarily recalling four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials.

The antibiotic, which is used in hospitals, is being recalled because 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.” (http://www.fda.gov/oc/po/firmrecalls/hanford02_06.html)

Hospitals, clinics, and users should stop using the affected lots immediately.

Cefazolin for Injection, USP is used to treat skin and skin structure, respiratory, and other infections.

Hanford Pharmaceuticals Inc 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.

The letter advises customers and users to 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 believe they may have experienced an adverse reaction to the recalled product should seek medical attention.  Patients or users can contact the company at (315) 476-7418.

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

Any adverse reactions or problems experienced due to 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 telephone 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.

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