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SafetyAlerts
December 6, 2000

AHP Recalls Conjugated Estrogen Tablets

Rouses, 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.

PRODUCT
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
(NDC #0046-0867-91)
b) Premarin(r) Tablets (conjugated estrogens tablets), 0.9mg, 90-count bottles. NDC #62584-864-90)
c) Premarin(r) Tablets (conjugated estrogens tablets), 1.25mg, 100-count bottles NDC #0046-0866-81
d) Premarin(r) Tablets (conjugated estrogens tablets), 2.5mg, 100-count bottles. NDC #0046-0865-81.

Recall #D-044/047-1.

CODE
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.

MANUFACTURER
Wyeth-Ayerst Laboratories, Rouses, New York.

RECALLED BY
AmeriSource Health Services Corporation, doing business as American Health Packaging (AHP) (relabeler/repacker/ distributor), by mail and fax on October 26, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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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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.