The standard physician sample pack of Allergan’s Taytulla birth control pills should have 24 pink capsules that contain hormones with four maroon capsules at the end of the package cycle that do not have hormones. However, 170,000 packages had four maroon placebos located at the beginning of the treatment cycle.
The standard physician sample pack of Allergan’s Taytulla birth control pills should have 24 pink capsules that contain hormones with four maroon capsules at the end of the package cycle that do not have hormones. However, 170,000 packages had four maroon placebos located at the beginning of the treatment cycle.
Allergan recalled the packs, and in a statement, said, “As a result of this packaging error, oral contraceptive capsules that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. 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.”
The lot numbers are 5620706 with an expiration date of May 2019.
The company indicated they found out about the problem from a physician report. The recall is voluntary and affects 168,768 packs. They have been in circulation since August 2017.
Taytulla (ethinyl estradiol) was approved by the U.S. Food and Drug Administration (FDA) in 2013.
Allergan, The Washington Post reports, said, “An investigation has been completed at the packaging site. 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.”
To date, no unintended pregnancies, as a result, have been reported.
Drug recalls related to packaging issues are not unheard of, although due to the nature of this recall—potential unwanted pregnancies—it’s getting plenty of media attention. For example, in 2012, Boehringer Ingelheim recalled a single lot of Pradaxa (dabigatrain etexilate) in the U.S. and Puerto Rico. The drug is used to decrease the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). In that case, the defect in the packaging might have compromised the integrity of the bottle, allowing moisture to get it, degrading the drug.
The FDA has a database that shows current recalls. Allergan’s Taytulla is the most recent one, but the database shows six others for the month of May alone, including Shadow Holdings’ X-Jow, Acne Shave, recalled because of possible bacterial contamination; MBI Distributing’s homeopathic products for lack of adequate manufacturing controls; Shoreside Enterprises’ 7K and Poseidon dietary supplements, because of undeclared Sildenafil and Tadalafil; Apotex Corporation’s Piperacillin and Tazobactam for Injection because of elevated levels of impurities; AuroMedics Pharma’s Piperacillin and Tazobactam for Injection because of glass particulates; and AuroMedics’ Ampicillin and Sulbactam because of visible particulate matter.
In an article in PharmTech advocating the advantages and necessities of a warehouse execution system (WES), Dave Williams writes, “There are many reasons for recalls in the pharmaceutical industry, including packaging defects, contamination of a product, improper testing of a product, or inherent safety problems that could harm a patient or user. Other pharmaceutical recall causes are due to dangerous side effects, the creation of a safer drug alternative, or improper use of the drug that causes serious injury or death.”
