Women taking birth control pills should always check new packages carefully, as there have been instances of birth control pills being packaged in the wrong order, leaving users at an increased risk of unintended pregnancy.
About a year ago, Manufacturer Lupin Pharmaceuticals recalled their Mibelas 24 Fe pills because of a packaging error that increased the risk of pregnancy. In May 2018, Allergan recalled thousands of sample packs of their Taytulla birth control pills because of the same type of packaging error.
Lupin Pharmaceuticals Recalls Birth Control Due to Packaging Error
On May 25, 2017, the FDA announced the Lupin recall on the agency’s website. Lupin implemented the recall because of a customer complaint regarding the packaging error. The agency stated that the manufacturer had recalled Lot# L600518 of the Mibelas 24 Fe tablets, with an expiration date of May 2018.
Mibelas 24 Fe is an oral contraceptive distributed in blister packs containing 28 tablets, 24 of which are active and 4 of which are inactive. In the incorrectly packaged product, as reported by the customer, the tablets had been rotated 180 degrees, placing the placebo or “blank” pills at the beginning of the treatment cycle instead of the end. The error also obscured the lot number and expiration date.
Women taking Mibelas 24 Fe in the wrong order were at an increased risk of unexpected pregnancy. The FDA added that in patients for whom pregnancy could be dangerous or who were taking medications that could harm a fetus, an unintended pregnancy could cause “significant adverse maternal or fetal health consequences, including death.”
At the time of the recall, no injuries had been reported. Lupin sent letters to customers informing them of the recall and told consumers with the affected products to notify their physicians and return the products to their place of purchase. Customers could also call 1-800-399-2561 between the hours of 8:00 a.m. and 5:00 p.m. EST Monday through Friday.
Allergan Recalls Taytulla Because of Packaging Error
In May 2018, Allergan announced that they were recalling about 170,000 units of Taytulla birth control after receiving a report of a packaging error in a sample pack. Sample packs are given to doctors by a manufacturer to share at no cost with patients. One of the doctors who had received sample packs of Taytulla notified the manufacturer that he had found that in one pack the 4 inactive placebo pills were placed at the start of the month rather than at the end of the month where they belonged.
As with the mispackaged Mibelas 24 Fe, the Taytulla packing error increases a user’s risk of unintended pregnancy, as well as breakthrough bleeding. The recalled Taytulla are sample packs from Lot# 5620706 with an expiration date of May 2019. The mispackaged sample packs were distributed to doctors between August 2017 and May 2018.
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