CORRECTING and REPLACING Lupin Pharmaceuticals Announces a Nationwide Recall of MibelasTM 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1mg/0.02mg Chewable Tablets and Ferrous Fumarate 75mg) Tablets

Recall Due to Out of Sequence Tablets and Missing Expiry/Lot Information

Correct presentation: Mibelas 24 Fe (Photo: Business Wire)

Correct presentation: Mibelas 24 Fe (Photo: Business Wire)

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CORRECTION...by Lupin Pharmaceuticals Inc.

BALTIMORE--()--Please replace the photo captions for the release dated May 26, 2017 with the accompanying corrected captions.

The release reads:

LUPIN PHARMACEUTICALS INC. ANNOUNCES A NATIONWIDE RECALL OF MIBELASTM 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 1MG/0.02MG CHEWABLE TABLETS AND FERROUS FUMARATE 75MG) TABLETS

Recall Due to Out of Sequence Tablets and Missing Expiry/Lot Information

Lupin Pharmaceuticals Inc. announced today that it has voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order. For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death. To date there have been no reports of such adverse events.

This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. These products are packaged in blister packs containing 28 tablets: 24 white/off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side. This product was distributed Nationwide in the U.S.A. to wholesalers, clinics and retail pharmacies.

NDC     Lot No     Expiration

68180-911-11 (Wallet of 28 tablets)
68180-911-13 (Carton of 3 wallets)

L600518 05/31/2018
 

Lupin is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers who have the affected product should notify their physician and return the product to the pharmacy or place of purchase.

Consumers with questions regarding this recall can contact Lupin at 1-800-399-2561, 8:00 am to 5:00 pm EDT, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Contacts

Lupin Pharmaceuticals
Consumer: 1-800-399-2561
Media: Arvind Bothra, arvindbothra@lupin.com

Release Summary

Baltimore, Maryland, Lupin Pharmaceuticals Inc. announced today that it has voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe Tablets at the consumer level.

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Contacts

Lupin Pharmaceuticals
Consumer: 1-800-399-2561
Media: Arvind Bothra, arvindbothra@lupin.com