notyard
10-25-2008, 10:27 AM
U.S. FDA class III recall:
PRODUCT
Detrol (tolterodine tartrate) tablets, 2mg, blister strips in unit dose carton (10 blisters x 14 tablets), Rx only, For institutional use only, NDC 0009-4544-01, Recall # D-023-2009
CODE
Lot C081255, exp. April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc, New York, NY, by letters on September 12, 2008.
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
The barcode on the blister strip incorrectly encodes NDC for 1mg Detrol. Barcode on outer carton is correct. All human-readable text is correct.
VOLUME OF PRODUCT IN COMMERCE
525 cartons (10 blisters x 14 tablets each)
DISTRIBUTION
Nationwide
PRODUCT
Detrol (tolterodine tartrate) tablets, 2mg, blister strips in unit dose carton (10 blisters x 14 tablets), Rx only, For institutional use only, NDC 0009-4544-01, Recall # D-023-2009
CODE
Lot C081255, exp. April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc, New York, NY, by letters on September 12, 2008.
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
The barcode on the blister strip incorrectly encodes NDC for 1mg Detrol. Barcode on outer carton is correct. All human-readable text is correct.
VOLUME OF PRODUCT IN COMMERCE
525 cartons (10 blisters x 14 tablets each)
DISTRIBUTION
Nationwide