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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Recall Number D-141-12013
Classification Class III
Code Info 0.9 mg: 512348A
Product Distributed Qty 5439 bottles
Reason For Recall Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Event Detail

Event Id 64014
Product Type Drugs
Status Ongoing
Recalling Firm Warner Chilcott Company LLC
City Fajardo
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide