FDA recall warns of risk for unintended pregnancy

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A packaging error is prompting Lupin Pharmaceuticals to recall one lot of Mibelas 24 Fe birth control pills, the Food and Drug Administration announced on Saturday.

In the recalled lot, the non-hormonal placebo tablets appear at the beginning of the pack, as opposed to the end, making the order in which the pills are intended to be taken unclear. The error also means that the lot number and expiration date are no longer visible.

“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,” according to the recall announcement.

So far, no such effects have been reported, according to the FDA.

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“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,” said the announcement.

Lupin is sending letters to distributors and consumers that may have received the affected lot. The lot number is L600518 and the pills are set to expire in May 2018, according to the recall announcement.

 

Tags Birth control Food and Drug Administration Product Issues Unintended pregnancy

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