Allergan is recalling physician sample packs of the birth control pills Taytulla after receiving a physician report that four of the placebo capsules were placed out of order with the first four days of therapy having four non-hormonal capsules instead of active ones. The reversing of the order may not be apparent to either new users or previous users, increasing the likelihood of taking the capsules out of order. This error could put the user at risk for unintended pregnancy.
Taytulla is a contraceptive used by women to prevent pregnancy.
The recall involves lot number 5620706 of Taytulla softgel capsules containing the hormones norethindrone acetate and ethinoly estradiol and the placebo capsules ferrous fumarate. Affected pills have the NDC of 0023-5862-31 on the outer carton, 0023-5862-28 on the blister card, and 0023-5862-29EN1216XX2 on the blister box. Affected blister cards have the expiration date of May 2019.
The recall lot involves about 17,000 packs of Taytulla, which were distributed to health care providers nationwide since Aug. 27, 2017.
Allergan is notifying medical professionals who received the recalled birth control pills and advising women who have used a Taytulla sample pack from the recalled lot to consult with their physician if they are concerned they may be affected by this issue.
Any adverse events or side effects related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice