Drug product
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.
D-1502-2020
Product summary
- Event
- Event 86108
- Status
- Terminated
- Classification
- Class II
- Quantity
- 560,922 Pouches
- Official record key
drug-enforcement:D-1502-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Code information: Lot #s: L900017, L900070, Exp. 12/31/2020; L900589, Exp. 03/31/2021; L901085, Exp. 04/30/2021; L901008, Exp. 06/30/2021; L901641, L901735, Exp.10/31/2021.
Distribution pattern: Nationwide within the U.S.
Derived failure modes
-
Potency or specification failure
Out of specification