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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 Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Recall Number D-304-2013
Classification Class III
Code Info Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
Product Distributed Qty 17,136 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