FDA recall D-303-2013

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

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-303-2013