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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of CROFAB (Crotalidae Polyvalent Immune Fab (Ovine)-Protherics

DATE RECALL INITIATED:

October 29, 2007

PRODUCT / LOT NUMBER / EXPIRATION DATE:

CROFAB - Crotalidae Polyvalent Immune FAB (Ovine) / 200623 / May 2008

MANUFACTURER:

Protherics
Wales, United Kingdom

REASON:

The recall of CroFab has been initiated due to sub-potency of this lot of product at the 24 month stability point. Past use of this product has not compromised patient safety since CroFAB is administered by titrating the dose to the patient's response. Therefore, patients may have required more of this lot of product in order to respond appropriately. Consignees have been asked to contact the manufacturer to arrange for product return.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002