Drug 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
D-0119-2017
Product summary
- Event
- Event 75455
- Status
- Completed
- Classification
- Class III
- Quantity
- 221,017 tablets
- Official record key
drug-enforcement:D-0119-2017
Official wording
Reason: Subpotent Drug; Ethinyl Estradiol
Code information: Lot Numbers (a) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent