FDA recall D-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.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

Distribution

Nationwide within the U.S.

Key facts

Status

Terminated

Initiation date

2020-07-21

Report date

2020-08-19

Termination date

2022-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1502-2020