FDA recall D-0122-2017

Product

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Reason for recall

Subpotent Drug; Ethinyl Estradiol

Distribution

Nationwide and Puerto Rico

Key facts

Status

Completed

Initiation date

2016-09-27

Report date

2016-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0122-2017