Allergan Issues Voluntary Recall of One Lot of Oral Contraceptive

Allergan has issued a voluntary nationwide recall in the US of one lot of the oral contraceptive, Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg, 6 x 28 physicians’ sample pack, due to a packaging error of misplaced capsules.

Allergan identified that four placebo capsules were placed out of order in a sample pack of Taytulla. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of the packaging error, oral contraceptive capsules can be taken out of sequence, and place the user at risk for contraceptive failure and unintended pregnancy.

Allergan is notifying customers by a recall letter and is arranging for return of all recalled sample pack products of the lot expiring in May 2019.

Source: Allergan and US Food and Drug Administration

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