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Class I Contraceptive Tablet Recall


August 24, 2017

A packaging error has prompted Lupin Pharmaceuticals Inc. to recall 1 lot of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets, according to the August 23, 2017, US Food and Drug Administration (FDA) Enforcement Report.

The contraceptive tablets in the 28-tablet blister packs are out of sequence, the report warned, with the first 4 pills in the packet placebo rather than active.

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“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,” Lupin Pharmaceuticals stated in a company announcement (May 25, 2017). “The reversing of 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.”

The recall affects 28-tablet wallets (NDC 68180-911-11) and 3-wallet cartons (NDC 68180-911-13) from lot L600518, which has an expiration date of May 31, 2018. The tablets were distributed nationwide to wholesalers, clinics, and retail pharmacies.

Lupin Pharmaceuticals voluntarily initiated the recall May 16, 2017. On August 15, 2017, the FDA designated it Class I, indicating reasonable probability that use could cause serious adverse health consequences.

Mibelas 24 Fe is available with a prescription for the prevention of pregnancy.

Jolynn Tumolo

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