Par Pharmaceutical, Inc. recalls Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablet
Recalled November 9, 2016 · FDA recall D-0122-2017 · Par Pharmaceutical
Hazard
Subpotent Drug; Ethinyl Estradiol · FDA Class III
Units
278,406 tablets
Sold at
Nationwide and Puerto Rico
Description
Subpotent Drug; Ethinyl Estradiol
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
Manufacturer(s)
Par Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →