February 7, 2003
Robins, A.H./Division of American Home
Products Has Recalled Premphase Tablets
The Food and Drug
Administration (FDA) released the following information.
a) Premphase Tablets, (conjugated estrogens 0.625mg and
medroxyprogesterone 5mg) dial dispenser containing 28
tablets, Rx only. Recall # D-067-3.
b) Premarin Tablets (conjugated estrogens) 0.625 mg, Rx
only, unit dose packages of 100 (NDC 0046-0867-99),
bottles of 100 (NDC 0046-0867-81) and bottles of 5000
(NDC 0046-0867-95), Recall # D-068-3.
a) 9001385, Exp. 2/03; 9001386, Exp. 2/03
b) 100''s - lot #9001216, exp 5/03 5000''s - lot #9000986,
exp 5/05 unit dose 100''s - lot #.
Robins, A.H./Division of American Home Products, Richmond, VA, by letter
issued November 18, 2002, via certified mail. Firm initiated recall is
Dissolution; failure to meet specifications at the 24 month/2-hour timepoint.
VOLUME OF PRODUCT IN COMMERCE
239,896 various size dispensers.