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 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