The U.S. Food and Drug Administration (FDA) announced a nationwide recall of a batch of birth control pills that may not work for the intended usage. Instead of preventing pregnancies, the errors in the batch of birth control pills may lead to unplanned pregnancies.

Mibelas 24 FE

Lupin Pharmaceuticals Inc., makers of the birth control pills sold under the name of Mibelas 24 FE (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) called for a voluntary recall after learning of a packaging error that could possibly lead to unplanned pregnancies.

According to the FDA, Lupin Pharmaceuticals Inc. announced a voluntary recall on the oral contraceptive last May 25 due to a confirmed complaint regarding a packaging error that reversed the tablet orientation of the pills. Because the blister was rotated by 180 degrees, the expiration date and lot number are no longer visible, and more importantly, the first four pills in the pack had non-hormonal placebo tablets instead of active ones.

As a result, the pills may have been taken out of the intended order, therefore placing their consumers at risk of unplanned pregnancies and contraceptive failure. Further, for users of the birth control pills in whom a pregnancy may prove risky, or those that are also taking accompanying pills with teratogenic side effects along with the recalled product, an unplanned pregnancy may be a source of serious complications for both the mother and the fetus, including death.

The affected products are packaged in 28-day blister packs. Of the tablets, 24 are white to off-white, marked with the letters "LU" and "N81" on either side, while the other four tablets are marked with "LU" and "M22" on either side.

The said affected birth control products have a Lot No of L600518, with NDC numbers of 68180-911-11 for the 28-tablet pack, and 68180-911-13 for the carton of three wallets. These also have an expiry date of May 31, 2018.

Lupin Pharmaceuticals Inc. is arranging for the return of all affected products from markets across the state, and the FDA recommends all individuals affected by the recall to return the product to their place of purchase and to notify their physician of the possibly mistaken pill intake.

No reports of adverse effects have been reported to the FDA, but any questions about the recall can be directed to Lupin Pharmaceuticals Inc. at 1-800-399-2561. Any adverse effects from the use of the product may be reported to the FDA's MedWatch program.

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