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SafetyAlerts
June 4, 2003

Richmond Division of Wyeth Has Recalled Premarin and Premphase Tablets

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

PRODUCT
a) Premarin Tablets (conjugated estrogens tablets, USP), 0.625 mg,
100 tablet unit dose packages;
100 tablet bottles; and 5,000 tablet bottles. Rx only.
Recall # D-263-3;
b) Premphase Tablets, 0.625 mg/5 mg (conjugated estrogens 0.625 mg
and medroxyprogesterone acetate 5 mg tablets), Ez-dial dispenser
containing 28 tablets, Rx only. Recall # D-264-3.

CODE
a) Lot #s: A09049 exp. April 2004 (100-tablet bottles);
A09041 exp. April 2004 (5,000-tablet bottles);
A09067 exp. April 2004 (100-tablet unit dose packages);
b) Lot #s: A09065 Exp. 11/03; A12270 Exp. 12/03; A09069, Exp. 12/03.

RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters on/about May 16, 2003. Firm initiated recall is ongoing.

Manufacturer is: Wyeth Pharmaceuticals, Inc., Rouses Point, NY.

REASON
Dissolution failure; 18 month stability station-2 hour time point.

VOLUME OF PRODUCT IN COMMERCE
111,605 units.

DISTRIBUTION
Nationwide.

 
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Health Professional:

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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.