Dive Brief:
- Allergan has issued a U.S.-wide voluntary recall of 168,768 packs of Taytulla oral contraceptives after a packaging error that could put women at risk of failure of birth control. These packs were supplied to physicians as samples.
- When packaged correctly, the 28-day sequence includes 24 active pink softgel capsules (norethindrone acetate and ethinyl estradiol) and four maroon placebo capsules, containing an iron supplement. In the incorrectly-packaged lot identified through a physician report, the placebo capsules were at the beginning of the sequence rather than the end.
- Allergan has written to customers to arrange for return of samples from lot# 5620706 (expiry May 2019), and affected consumers should notify their physicians.
Dive Insight:
Many oral contraceptives are taken over 21 days, with a seven day period of no pills, allowing seven hormone-free days. To make the routines easier to remember, some packs contain 21 or 24 active pills, with the remaining days of the 28-day cycle completed with placebo pills. Some formulations have 84 days of active pills, with seven placebo pills providing the hormone-free days.
Missing pills can increase the risk of accidental pregnancy; in the case of the incorrectly packaged Taytulla softgel capsules, taking the placebo pills at the beginning of the 28 days rather than at the end effectively equates to missing four days' worth of pills.
"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. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician," Allergan said in a statement.
In May 2017, Lupin Pharmaceuticals recalled a single lot of Mibelas 24 Fe, a chewable formulation of 24 norethindrone acetate and ethinyl estradiol tablets and four iron supplement tablets, also for a sequence error. The blister pack was rotated 180 degrees in the wallet, reversing the tablet orientation and covering the lot number and expiry date.