Allergan is recalling one batch of its Taytulla birth control pills which were incorrectly packaged. The pills – labelled with the Lot# 5620706 and an expiry date of May-2019 – were designated as a 6×28 physicians sample pack. The recall will affect nearly 170,000 packages of Taytulla which were distributed to physicians through Nationwide.
“An investigation has been completed at the packaging site,” said Allergan. “Given the nature of the issue, controls and inspections in place on the packaging line, the recall is limited to one lot of Taytulla. At this time, no other units with the defect have been identified within the lot or within any other Taytulla lot.”
After receiving a report from a physician, Allergan found that this lot of Taytulla contained placebo pills, as opposed to those capsules containing the active ingredients, in the first four days of each pack.
This means that women taking the affected lot are at risk of becoming pregnant if they don’t currently use a secondary form of contraception. As a result, Allergan is urging all patients who have used a sample pack of Taytulla provided by their physician since August 27, 2017 to contact their healthcare provider.
“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,” said the recall issued by Allergan. “If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.”
Taytulla is a 28-count oral contraceptive that can prevent pregnancy in women when taken correctly. The 24 pink softgels included in the blister pack contain the contraceptive hormones, while the remaining four capsules contain no active ingredient and are designed to be taken at the end of the cycle. Both the active ingredient-containing capsules and the placebo pills are imprinted with the letters “WC.”
The FDA is aware of Allergan’s Taytulla recall and will be accepting adverse event reports through its MedWatch Adverse Event Reporting Program. Allergan will be accepting recalled packages through physicians’ offices. At this time, no unintended pregnancies have been reported.
Allergan’s Taytulla was originally approved by the FDA in 2013.