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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 0.9 mg: 512348A Class III Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles 5439 bottles D-141-12013
Femtrace 0.45 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 0.45 mg: 505969A Class III Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles 3155 bottles D-142-2013
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