Allergan recalls 170,000 birth control packs in US over pregnancy fears

pharmafile | May 30, 2018 | News story | Research and Development Allergan, FDA, Taytulla, US, birth control, pharma 

Allergan has issued a voluntary recall of its birth control medication in the US marketplace after an error in packaging was identified that could mean users are at a higher risk of falling pregnant due to the medication not working as intended, it has emerged.

The recall concerns physician sample packs of Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), specifically lot #5620706 with the expiry date of May 2019, meaning nearly 170,000 units could be affected.

Each sample pack of Taytulla is intended to contain 24 active pink pills to be taken daily, followed by four inactive maroon pills. The problem, identified through a physician report, lies in the fact that, in at least one pack, this order has been reversed, with the inactive pills coming first. This increases the likelihood that users will take the pills out of their intended order, potentially leading to unwanted pregnancy through a failure of the medication.

“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,” Allergan said in a recall notice. “If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.”

Matt Fellows

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