June 4, 2003
Richmond Division of Wyeth Has Recalled
Premarin and Premphase Tablets
The Food and Drug Administration (FDA) has released the following
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.
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.
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.
Dissolution failure; 18 month stability station-2 hour time point.
VOLUME OF PRODUCT IN COMMERCE