Par Pharmaceutical, Inc. recalls Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate table
Recalled November 9, 2016 · FDA recall D-0123-2017 · Par Pharmaceutical
Hazard
Subpotent Drug; Ethinyl Estradiol · FDA Class III
Units
44,127 tablets
Sold at
Nationwide and Puerto Rico
Description
Subpotent Drug; Ethinyl Estradiol
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
Manufacturer(s)
Par Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →