FOOD AND DRUG
ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 4, 1998PRODUCT
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). |
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