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SafetyAlerts
February 7, 2003

A.H. Robins Has Recalled Premphase Tablets

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

PRODUCT
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.

CODE
a) Lot 9001385, Exp 2/2003; Lot 9001386, Exp 2/2003
b) Lot 9001216, Exp 5/03; Lot 9000986, Exp 5/05;
Lot 9000846, Exp 5/05.

RECALLING FIRM/MANUFACTURER
A.H. Robins, Richmond, VA, by letter dated 11/18/02. Firm initiated recall is ongoing.

REASON
Dissolution; failure to meet specifications at the 24 month/2-hour timepoint.

VOLUME OF PRODUCT IN COMMERCE
a) Premphase - 41,220 units
b) Premarin - 198,676 units.

DISTRIBUTION
Nationwide.

 

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.