December 6, 2000AHP Recalls Conjugated Estrogen
NY (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that AmeriSource Health Services Corporation, doing
business as American Health Packaging (AHP) is recalling certain conjugated estrogen
tablets because of manufacturer's dissolution failure.
This is the first public notice of
this Class III
recall issued by FDA.
Conjugated estrogen tablets, Rx, repackaged in bottles as follows:
a) Premarin(r) Tablets (conjugated estrogens tablets), 0.625 mg, 100-count (NDC
0046-0867-81) & 1,000-count
b) Premarin(r) Tablets (conjugated estrogens tablets), 0.9mg, 90-count bottles. NDC
c) Premarin(r) Tablets (conjugated estrogens tablets), 1.25mg, 100-count bottles NDC
d) Premarin(r) Tablets (conjugated estrogens tablets), 2.5mg, 100-count bottles. NDC
Lot Numbers: 8086 EXP 8/6/00; 8482 EXP 9/25/00; 8898 EXP 11/10/00; 8923, EXP 11/13/00;
11210A, EXP 6/28/01; 11210B EXP 7/9/01; 11210C EXP 7/20/01; 11492A EXP 8/10/01; 11492B EXP
8/30/01; 11935 EXP 9/29/01; 12336 EXP 11/16/01; 12878 EXP 2/25/02; 13496 EXP 1/17/02.
Wyeth-Ayerst Laboratories, Rouses, New York.
AmeriSource Health Services Corporation, doing business as American Health Packaging (AHP)
(relabeler/repacker/ distributor), by mail and fax on October 26, 2000. Firm-initiated
14,785 bottles were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafetyAlerts subscribers December
6, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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