Lupin Pharmaceuticals Inc. recalls Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/7
Recalled August 19, 2020 · FDA recall D-1502-2020 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. · FDA Class II
Units
560,922 Pouches
Sold at
Nationwide within the U.S.
Description
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
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.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →