FDA recall D-304-2013

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.

Reason for recall

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.

Distribution

US Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-02-15

Report date

2013-05-08

Termination date

2014-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fajardo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-304-2013