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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/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA
Recall Number D-630-2013
Classification Class III
Code Info Lots: E67324 & E96152 Exp: 06/13
Product Distributed Qty 432,657 blister cards
Reason For Recall Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

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