Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Recall Number: D-0121-2017

Firm: Par Pharmaceutical, Inc.

Classification: Class III

Status: Completed

Report Date: 20161109

Initiation Date: 20160927

Termination Date:

Subpotent Drug; Ethinyl Estradiol

Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811