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May 28, 2003

Alpharma Purepac Has Recalled Bisoprolol Fumarate and Hydrochlorothiazide Tablets

(SafetyAlerts) - 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.

 
Selected Recent Recalls


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During 2000 there were over
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.