Drug product
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
D-0123-2017
Product summary
- Event
- Event 75455
- Status
- Completed
- Classification
- Class III
- Quantity
- 44,127 tablets
- Official record key
drug-enforcement:D-0123-2017
Official wording
Reason: Subpotent Drug; Ethinyl Estradiol
Code information: Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent