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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description 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 0046-0875-11
Recall Number D-631-2013
Classification Class III
Code Info Lots: E77055, E96153, & F11111 Exp: 06/13
Product Distributed Qty 135,520 blister cards
Reason For Recall 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.

Event Detail

Event Id 65393
Product Type Drugs
Status Ongoing
Recalling Firm Pfizer Inc.
City New York
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico