Some U.S. women given a sample package of an Allergan birth control drug got more than they bargained for: the risk of an unwanted pregnancy.
The Dublin-based drugmaker, which has found itself in this kind of situation before, on Tuesday said it had issued a voluntary nationwide recall of 168,768 physician sample packs of Taytulla capsules. The action came after a physician discovered a package in which the first four days of therapy had four nonhormonal placebo capsules instead of active capsules.
The recall notice said that a Taytulla pill pack is a 28-count blister card with 24 "active" pink softgel capsules, the ones with the hormones, which are followed by 4 maroon softgel capsules that don’t have hormones. The packages are from lot #5620706, with an expiration date of May 2019.
Taking the capsules out of sequence because of the packaging error “may place the user at risk for contraceptive failure and unintended pregnancy,” Allergan said, adding the reversed of order may not be apparent to new users, or even previous users, of the product.
This kind of packaging error is not unheard of. In 2015, shortly after Allergan and Actavis completed a merger, Actavis recalled 26 lots, amounting to 511,283 boxes, of Lutera birth control pills after discovering that package inserts were missing. The pills were manufactured for Actavis by Patheon, the report indicates. Teva now owns most of the Actavis portfolio.
Last year, Endo’s Par recalled 162 lots, comprising 1,365,559 tablets, of its Gildess contraceptive in different dose sizes. The tablets were manufactured for Endo’s Qualitest Pharmaceuticals unit by Patheon at a plant in Ontario, Canada. In that case, the pills, a combination of norethindrone acetate and ethinyl estradiol, were recalled for being subpotent for ethinyl estradiol.