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SafetyAlerts
November 21, 2002

Wyeth Pharmaceuticals Has Recalled Premarin Tablets

(Premarin is used to treat menopausal symptoms.)

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

PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP) 1.25 mg, 100, 1000 and 5000 count bottles, Rx, only. Recall # D-053-3.

CODE
100s: Lot 9981205, Exp. 3/02
1000s: Lot 9981348, Exp. 3/03
5000s: Lot 9981207, Exp. 3/03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Richmond, VA, by letters dated October 14, 2002.
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
Firm initiated recall is ongoing.

REASON
Failure to meet dissolution specifications.

VOLUME OF PRODUCT IN COMMERCE
100s: 1,487 btls; 1000s: 1,514 btls; 5000s: 1,800 btls.

DISTRIBUTION
Nationwide.

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November 22, 2002
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