Warner Chilcott Company LLC recalls Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), R
Recalled May 8, 2013 · FDA recall D-304-2013 · 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
17,136 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
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.
Manufacturer(s)
Warner Chilcott Company LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →