notyard
04-15-2009, 09:12 AM
FDA class II recall:
PRODUCT
Paroxetine 40mg Tablets USP; 90 Tablets NDC 0093-7121-98; Rx only. NDC number 0093-7121-98. Recall # D-203-2009
CODE
Lot number: 09Y005 exp 12/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated August 27, 2008.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Superpotent; exceeds weight and potency requirements.
VOLUME OF PRODUCT IN COMMERCE
13,773 bottles
DISTRIBUTION
Nationwide
PRODUCT
Paroxetine 40mg Tablets USP; 90 Tablets NDC 0093-7121-98; Rx only. NDC number 0093-7121-98. Recall # D-203-2009
CODE
Lot number: 09Y005 exp 12/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated August 27, 2008.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Superpotent; exceeds weight and potency requirements.
VOLUME OF PRODUCT IN COMMERCE
13,773 bottles
DISTRIBUTION
Nationwide