Class II
Terminated
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.
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- July 21, 2020
- Posted
- August 19, 2020
- Recall Number
- D-1502-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 560,922 Pouches
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Distribution
Nationwide within the U.S.
Lot / Code Info
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.
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