notyard
07-08-2009, 12:11 PM
FDA class III recall:
PRODUCT
Citalopram Hydrobromide Tablets, USP, 40 mg, 100 tablet bottles, Rx only, NDC 57664-509-88. Recall # D-1336-2009
CODE
Lot # 81940A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI, by telephone beginning on December 31, 2008. Firm initiated recall is complete.
REASON
The product does not dissolve as rapidly as required by its specifications.
VOLUME OF PRODUCT IN COMMERCE
19,392 bottles
DISTRIBUTION
Nationwide
PRODUCT
Citalopram Hydrobromide Tablets, USP, 40 mg, 100 tablet bottles, Rx only, NDC 57664-509-88. Recall # D-1336-2009
CODE
Lot # 81940A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI, by telephone beginning on December 31, 2008. Firm initiated recall is complete.
REASON
The product does not dissolve as rapidly as required by its specifications.
VOLUME OF PRODUCT IN COMMERCE
19,392 bottles
DISTRIBUTION
Nationwide