D-1502-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 19, 2020
- Initiation Date
- July 21, 2020
- Termination Date
- January 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 560,922 Pouches
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Distribution Pattern
Nationwide within the U.S.
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.