Par Pharmaceutical, Inc. recalls Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (ND
Recalled November 9, 2016 · FDA recall D-0119-2017 · Par Pharmaceutical
Hazard
Subpotent Drug; Ethinyl Estradiol · FDA Class III
Units
221,017 tablets
Sold at
Nationwide and Puerto Rico
Description
Subpotent Drug; Ethinyl Estradiol
Product
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), 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 →