FDA-Drug2016-11-09Class III

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

Par Pharmaceutical, Inc.
Hazard

Subpotent Drug; Ethinyl Estradiol

Sold states
Nationwide and Puerto Rico
Affected count
822,009 tablets
Manufactured in
1 Ram Ridge Rd, Chestnut Ridge, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0121-2017

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