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 tabl…

Recall date

September 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0123-2017

FDA classification

Class III

Brand / firm

Par Pharmaceutical, Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Subpotent Drug; Ethinyl Estradiol

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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