FDA-Drug2013-07-10Class III

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11

Pfizer Inc.
Hazard

Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.

Sold states
Nationwide and Puerto Rico
Affected count
135,520 blister cards
Manufactured in
235 East 42nd Street, N/A, New York, NY, United States
Products
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-631-2013

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