Recall: Mibelas 24 Fe Birth Control Pills

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer Lupin Pharmaceuticals has issued a voluntary recall for Mibelas 24 Fe due to a packaging error. Mibelas 24 Fe is one of several generic alternatives for Minastrin 24 Fe, a chewable birth control pill that comes with iron supplements.

This is a class I recall, the most serious type of recall, which means that there is a situation where there is a reasonable probability that use of the recalled medication may cause serious adverse health consequences or death. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

A manufacturer can voluntarily call their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication.

In this case, the manufacturer has voluntarily recalled Mibelas 24 Fe, with the knowledge of the FDA.

Why has Mibelas 24 Fe been recalled?

On May 25, 2017, Lupin initiated a recall due to a packaging error which has the potential to result in pregnancy. One blister in the affected packages was rotated 180 degrees, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible.

In the affected lot, the first four pills in the monthly pack have 4 non-hormonal placebo tablets instead of active tablets that contain medicine.

An unintended pregnancy may cause significant adverse consequences for maternal or fetal health, including death, for patients where a pregnancy is contraindicated, or in those taking other medication(s) that may have teratogenic effects (that can disturb the development of an embryo or fetus).

Which Mibelas 24 Fe packages were affected?

This recall applies to one lot and two NDCs (packages):

Drug: Mibelas 24 Fe
Manufacturer: Lupin Pharmaceuticals
Lot: #L600518
Expiration date: 5/31/2018
National Drug Codes (NDCs): 68180-0911-13 (carton of 3 wallets), 68180-0911-11 (wallet of 28 tablets)

The affected lot started shipping on March 15, 2017 to retail pharmacies and wholesale distributors in the US.

If you have any trouble finding the lot and NDC information on your prescription, please check with your pharmacist for more information. This may be an issue due to the cause of the recall—the packaging error means that the lot number and expiration date are not easily visible.

Is there any way I could have known about the packaging error by looking at my pill pack?

No. Whether you’ve been prescribed Mibelas 24 Fe before, or it’s your first time taking this prescription, you would not be able to tell that the tablets were in reverse order. This increases the risk that you could take the tablets out of order without realizing.

Have any other companies that make similar contraceptives been affected?

No. Only Mibelas 24 Fe from Lupin Pharmaceuticals is affected by the recall. Some similar birth control products you may be prescribed instead include:

Are patients who have taken this medication being notified?

Yes. A class I recall requires that the manufacturer notify patients.

What do I do if I think I have a recalled package of Mibelas 24 Fe?

First, DO NOT throw your package away—it must be returned to Lupin Pharmaceuticals for proper disposal in order for you to be reimbursed.

Contact Genco Pharmaceutical Services at 1-855-633-1428 to request a product return and reimbursement packet. Genco’s hours of operation are Monday through Friday, 7:30 am to 6 pm EST.

Once you receive your return packet, you can return the recalled medication with your pharmacy receipt using the prepaid FedEx Authorized Return Service shipping label. It will ship to the following address:

GENCO Pharmaceutical Services, a subsidiary of FedEx Supply Chain
6101 North 64th Street
Milwaukee, WI 53218

Where can I go to lean more information?

You can find the FDA safety announcement here.

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