Warner Chilcott Company LLC recalls Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx
Recalled May 8, 2013 · FDA recall D-303-2013 · Warner Chilcott
Hazard
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. · FDA Class III
Units
27,509 bottles
Sold at
US Nationwide and Puerto Rico
Description
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.
Product
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
Manufacturer(s)
Warner Chilcott Company LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →