The product is an oral contraceptive pill pack, known under the name Taytulla. It contains a 28-count blister card with 24 active pink capsules (which carry the hormone ethinyl), followed by four maroon placebo capsules, meant to be taken at the end of the cycle.
As a result of the packaging error, the four placebo capsules were placed at the start of the package instead. If taken out of sequence, the company has said, this “may place the user at risk for contraceptive failure and unintended pregnancy.”
They added that “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.”
The affected packs have been in circulation since August. The company is recalling all packs that expire in May 2019, and have the lot number ##5620706.
Allergan was alerted to the error by a physician in the US. Nearly 170,000 packs have been recalled.
The company, whose headquarters are in Dublin, released a statement stating that “at this time, no other units with the defect have been identified within the lot or within any other Taytulla lot.”
A similar error occurred in a batch of Mibelas 24 Fe tablets distributed by Lupin Pharmaceuticals in June last year.
Earlier this year, Natural Cycles, a contraceptive app with 700,000 users worldwide that became certified in the EU as a form of birth control in August 2017 received complaints after being linked to 37 women who visited the hospital for unwanted pregnancies.
The app uses an algorithm, along with factors such as temperature, to determine when a woman may be fertile. The company has launched an internal investigation with their clinical department to further look in to each case.