drugs Class III Updated 2013-05-08

Warner Chilcott Company LLC recalls Jevantique (norethindrone acetate and ethinyl estradiol) tab

Recalled 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.

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 # 507694A; exp 02/13 Lot # 510041C; exp 05/13
View official government recall

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