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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Recall Number D-303-2013
Classification Class III
Code Info Lot# 510122B; exp 04/13
Product Distributed Qty 27,509 bottles
Reason For Recall Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

Event Detail

Event Id 64459
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 2013-02-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide and Puerto Rico