Originally posted on The Wall Street Journal by Austen Hufford on May 29, 2018

Allergan AGN -3.97% PLC is recalling nearly 170,000 sample packs of its birth-control treatment Taytulla after placebo and active capsules were placed out of order, potentially raising the risk of an unintended pregnancy.

The drugmaker said Tuesday the physician sample packs of Taytulla were designed to have 24 active birth control pills, followed by four placebo pills, taken daily over the course of 28 days. Allergan, which attributed the issue to a packing error, said the four inactive pills were incorrectly placed at the start of the package. The company said it recently learned of the issue from a physician report and launched a voluntary recall of 168,768 packs.

Allergan said that oral contraceptive capsules taken out of sequence may place users at risk for contraceptive failure and unintended pregnancy. “The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order,” the company said.

The affected lot of Taytulla sample packs, which were sent to health-care providers, has been in circulation nationwide since August.

Allergan said it hasn’t received any reports of unintended pregnancies as a result of the packaging error in the recalled lot.

Taytulla, also called ethinyl estradiol, gained Food and Drug Administration approval in 2013.

Allergan shares slid more than 2% in late-morning trading Tuesday.


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