notyard
10-08-2009, 10:13 AM
FDA class II recall:
PRODUCT
Naproxen Tablets, USP, 500 mg tablets, 1000 tablets per bottle, Rx only, NDC 53746-190-10. Recall # D-1973-2009
CODE
Lot # HC06109, Exp 03/13
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Hauppauge, NY, by letter dated August 10, 2009. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug). Tablet Thickness. This product is being recalled because of a report of one oversized (thick) tablet.
VOLUME OF PRODUCT IN COMMERCE
986 bottles
DISTRIBUTION
Nationwide
PRODUCT
Naproxen Tablets, USP, 500 mg tablets, 1000 tablets per bottle, Rx only, NDC 53746-190-10. Recall # D-1973-2009
CODE
Lot # HC06109, Exp 03/13
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Hauppauge, NY, by letter dated August 10, 2009. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug). Tablet Thickness. This product is being recalled because of a report of one oversized (thick) tablet.
VOLUME OF PRODUCT IN COMMERCE
986 bottles
DISTRIBUTION
Nationwide