March 26, 2003
Robins, A.H./Division of American Home
Products Has Recalled PREMARIN Tablets
The Food and Drug
Administration (FDA) has released the following information.
a) PREMARIN Tablets, 0.9 mg (conjugated estrogens tablets,
USP), 100 tablet bottles, Rx Only. Recall # D-183-3.
b) Premarin tablets, 1.25 mg, (conjugated estrogens
tablets, USP), 5,000 count bottles, Rx Only.
Recall # D-184-3.
a) 9981732, Exp. August 2003; 9990073, Exp. August 2003.
b) 9000073, Exp. July 2004; 9010066, Exp. August 2003;
9010248, Exp. August 2003.
Robins, A.H./Division of American Home Products, Richmond, VA, by letters on
February 21, 2003. Firm initiated recall is ongoing.
Dissolution Failure: 5 hour time point.
VOLUME OF PRODUCT IN COMMERCE
a) 74,211 units;
b) 1,893 units.