The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Bisoprolol Fumarate and Hydrochlorothiazide Tablets,
2.5 mg/6.25mg, bottles of 100, Rx only. Recall # D-255-3;
b) Bisoprolol Fumarate and Hydrochlorothiazide Tablets,
5 mg/6.25mg, bottles of 100, Rx only. Recall # D-256-3;
c) Bisoprolol Fumarate and Hydrochlorothiazide Tablets,
10mg/6.25mg. bottles of 30, Rx only. Recall # D-257-3.

CODE
a) Lot No. 306M11 Exp Date 1/03; 460F21 Exp Date 10/03;
481C11 Exp Date 9/03; 575H11 Exp Date 5/03;
576H11 Exp Date 5/03; 870D21 Exp Date 5/03;
871D21 Exp Date 11/03; 872D21 Exp Date 11/03;
966E11 Exp Date 6/03; 967E11 Exp Date 6/03;
b) Lot No. 307M11 Exp Date 1/04; 308M11 Exp Date 1/04;
309M11 Exp Date 1/04; 361B11 Exp Date 3/03;
362B11 Exp Date 3/03; 482C11 Exp Date 3/03;
483C11 Exp Date 3/03; 577H11 Exp Date 10/03;
578H11 Exp Date 10/03; 873D21 Exp Date 5/04;
874D21 Exp Date 5/04; 875D21 Exp Date 5/04;
876D21 Exp Date 5/04; 968E11 Exp Date 6/03;
969E11 Exp Date 8/03;
c) Lot No. 310M11 Exp. Date 1/04; 363B11 Exp. Date 3/03;
579H11 Exp. Date 9/03; 580H11 Exp. Date 9/03;
877D21 Exp. Date 5/04; 878D21 Exp. Date 5/04;
879D21 Exp. Date 5/04; 970E11 Exp. Date 6/03.

RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter dated March 20, 2003 and sent via certified mail on March 21, 2003. Firm initiated recall is ongoing.

REASON
Impurity failure; product failed to meet the Bisoprolol Fumarate unknown impurity specification.

VOLUME OF PRODUCT IN COMMERCE
756,230 bottles.

DISTRIBUTION
Nationwide.