Recall
CROFAB (Crotalidae Polyvalent Immune Fab {Ovine})
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.