Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 4, 1998

PRODUCT
Prempro Tablets (Conjugated Estrogens
0.625mg/Medroxyprogesterone Acetate 2.5mg ), in
unit dose cartons of 28 tablets (14 tablets per
card) sold in cartons of 3, prescription hormone
replacement therapy.
NDC #0046-0875-01/02.

Recall #D-083-8.

CODE

Lot #9970927 EXP 7/99.

MANUFACTURER

Wyeth-Ayerst Laboratories, Rouses Point, New York.

RECALLED BY

Wyeth Ayerst Laboratories/Whitehall Robbins,
Richmond, Virginia, by letter dated January 29,
1998. Firm-initiated recall ongoing.

DISTRIBUTION

Mid-Western United States.

QUANTITY

24,931 cartons were distributed.

REASON

Content uniformity failure (medroxyprogesterone
acetate superpotent).

 

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.