Birth control packaging mistake could result in unintended pregnancy

Mibelas 23 Fe (FDA)

(WCMH) – A birth control packaging mix-up could lead to unintended pregnancies.

Lupin Pharmaceuticals recently announced a recall of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets.

A complaint to the company revealed 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.

As a result of the error, the first four days of therapy would have the patient taking four non-hormonal placebo tablets instead of active tablets.

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.

These products are packaged in blister packs containing 28 tablets: 24 white to 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 by phone 1-800-399-2561, 8:00 am to 5:00 pm EST, 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.

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