Allergan has issued a nationwide recall of Lot #5620706 – Exp. May 2019 – of its oral contraceptive Taytulla softgel capsules 1mg/20mcg sample packs.
Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is indicated for use by women to prevent pregnancy.
According to the Ireland-headquartered firm, a physician report identified that four placebo capsules in a sample pack were packaged out of order: "Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules."
The affected product is manufactured by Catalent Pharma Solutions and packaged at Sharp Packaging Solutions in Pennsylvania, Allergan spokesperson Lisa Brown told us.
In a statement released earlier today, Allergan 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.”
According to the firm, which is issuing recall letters to customers, the reversing of the order may not be apparent to product users, “increasing the likelihood of taking the capsules out of order.”
Sharp Packaging Solutions did not respond to a request for comment ahead of publication.