Recalls / Class II
Class IID-1502-2020
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.
- Affected 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.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 560,922 Pouches
- Distribution pattern
- Nationwide within the U.S.
Timeline
- Recall initiated
- 2020-07-21
- FDA classified
- 2020-08-13
- Posted by FDA
- 2020-08-19
- Terminated
- 2022-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1502-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.