FDA recall D-0123-2017

Par Pharmaceutical, Inc. · Class III · drug

Product

Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), 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-0123-2017