Drug product
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)
D-1565-2019
Product summary
- Event
- Event 83284
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12938 units
- Official record key
drug-enforcement:D-1565-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Code information: Lot L800050
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification