Reported Aug 19, 2020 · Terminated
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- 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
68180-911-11Carton contains 3 wallets of 28 tablets each
- NDC68180-911-13
- Distributed byLupin Pharmaceuticals, Inc., MD, 21200
- Manufactured byLupin Limited, India
- Lot codes and dates
Lot #s: L900017L900070Exp. 12/31/2020L900589Exp. 03/31/2021L901085Exp. 04/30/2021L901008Exp. 06/30/2021L901641L901735Exp.10/31/2021
- Amount recalled
- 560,922 Pouches
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
This product could cause temporary or reversible health problems — stop using it.
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