drugs Class III Updated 2013-05-08

Warner Chilcott Company LLC recalls Femhrt (norethindrone acetate and ethinyl estradiol) tablets

Recalled Product

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot# 507694B; exp 02/13
View official government recall

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