FDA-Drug2016-11-09Class III
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
Par Pharmaceutical, Inc.
Hazard
Subpotent Drug; Ethinyl Estradiol
Sold states
Nationwide and Puerto Rico
Affected count
221,017 tablets
Manufactured in
1 Ram Ridge Rd, Chestnut Ridge, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0119-2017Don't want to check this manually?
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