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.
Reported: August 19, 2020 Initiated: July 21, 2020 #D-1502-2020
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 560,922 Pouches
- Distribution
- Nationwide within the U.S.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 560,922 Pouches.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 19, 2020. Severity: Moderate. Recall number: D-1502-2020.
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