The FDA has released the following information.
PRODUCT
Amaryl tablets (Glimepiride), 4 mg, 100 tablet blister pack, Rx Only. Recall # D-332-3.
CODE
Lot number: 1054540.
RECALLING FIRM/MANUFACTURER
Aventis Pharmaceuticals Inc., Kansas City, MO, by letters on July 31, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure: stability (18 month test station).
VOLUME OF PRODUCT IN COMMERCE
7,032/100-tab boxes.
DISTRIBUTION
Nationwide.
PRODUCT
Amaryl tablets (Glimepiride), 4 mg, 100 tablet blister pack, Rx Only. Recall # D-332-3.
CODE
Lot number: 1054540.
RECALLING FIRM/MANUFACTURER
Aventis Pharmaceuticals Inc., Kansas City, MO, by letters on July 31, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure: stability (18 month test station).
VOLUME OF PRODUCT IN COMMERCE
7,032/100-tab boxes.
DISTRIBUTION
Nationwide.





