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Safety Alerts
July 27, 1999

Wyeth-Ayerst Laboratories Recalls Atenolol Tablets

Richmond, VA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Wyeth-Ayerst Laboratories is recalling Atenolol Tablets because of content uniformity failure.

PRODUCT
Atenolol Tablets USP packaged in:
a) 25 mg;
b) 50 mg;
c) 100 mg.
All three strengths were packaged and distributed in bottles of 100's and 1000's, Rx used in the management of hypertension. NDC Numbers:
25 mg:
Bottle of 100, NDC 0005-3218-43
Bottle of 1000 NDC 0005-3218-34
50 mg:
Bottle of 100 NDC 0005-3219-43
Bottle of 1000 NDC 0005-3219-34
100 mg:
Bottle of 100 NDC 0005-3220-43
Bottle of 1000 NDC 0005-3220-34.

Recall #D-287/289-9.

CODE
a) 25 mg,
Bottles of 100:
D454-909 (EXP 03/01)
D454-910 (EXP 03/01)
D457-101 (EXP 06/01)
D457-102 (EXP 06/01)
D457-103 (EXP 06/01)
D459-493 (EXP 09/01)
D459-386 (EXP 09/01)
D459-390 (EXP 09/01)
Bottles of 1000:
D457-100 (EXP 06/01)
D457-104 (EXP 06/01)
D459-385 (EXP 09/01)
D459-387 (EXP 09/01)
D459-389 (EXP 09/01)
b) 50 mg,
Bottles of 100:
D449-230 (EXP 07/00)
D453-456 (EXP 02/01)
D453-457 (EXP 02/01)
D457-107 (EXP 06/01)
D459-404 (EXP 09/01)
Bottles of 1000:
D449-040 (EXP 07/00)
D449-041 (EXP 07/00)
D449-042 (EXP 07/00)
D449-228 (EXP 07/00)
D449-229 (EXP 07/00)
D449-231 (EXP 07/00)
D451-212 (EXP 10/00)
D451-213 (EXP 10/00)
D451-318 (EXP 10/00)
D451-319 (EXP 10/00)
D453-453 (EXP 02/01)
D453-454 (EXP 02/01)
D453-455 (EXP 02/01)
D457-105 (EXP 06/01)
D457-106 (EXP 06/01)
D457-108 (EXP 06/01)
D458-707 (EXP 06/01)
D457-110 (EXP 06/01)
D457-111 (EXP 07/01)
D457-112 (EXP 07/01)
D457-113 (EXP 07/01)
D457-114 (EXP 07/01)
D459-398 (EXP 09/01)
D459-400 (EXP 09/01)
D459-402 (EXP 09/01)
D460-390 (EXP 10/01)
D460-391 (EXP 10/01)
D460-392 (EXP 10/01)
c) 100 mg,
Bottles of 100:
D459-520 (EXP 09/01)
D459-521 (EXP 09/01)
D461-521 (EXP 01/02)
Bottles of 1000:
D449-233 (EXP 07/00)
D457-115 (EXP 07/01)
D457-116 (EXP 07/01)
D457-117 (EXP 07/01)

MANUFACTURER
Wyeth-Ayerst Pharmaceuticals, Inc., Pearl River, New York.

RECALLED BY
Wyeth-Ayerst Laboratories, Richmond, Virginia, by letter sent on June 16, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Puerto Rico, Virgin Islands, Taiwan.

QUANTITY
583,586 bottles were distributed August 1997 to May 1999 as follows:
a) 25 mg: 347,824 bottles total: 330,463 bottles of 100 and 17,361 bottles of 1000
b) 50 mg: 196,773 bottles total: 126,098 bottles of 100 and 70,675 bottles of 1000
c) 100 mg: 38,989 bottles total: 33,919 bottles of 100 and 5,070 bottles of 1000.

 

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.