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 Id 64459

Product Type Drugs

Status Ongoing

Recalling Firm Warner Chilcott Company LLC, Fajardo, PR, US Territory

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