FDA-Drug2013-05-08Class III
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.
Warner Chilcott Company LLC
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.
Sold states
US Nationwide and Puerto Rico
Affected count
17,136 bottles
Manufactured in
Road 195, Km 1.1, Union Street, Fajardo, PR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-304-2013Don't want to check this manually?
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