(WHDH) — Allergan has issued a nationwide recall for widely-used birth control pills due to a packaging error that could lead to an unintended pregnancy, according to the Food and Drug Administration.
Through a recent physician report, Allergen learned that four placebo capsules were placed out of order in a sample pack of Taytulla. The first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
The recall covers nearly 170,000 sample packs with a 28-count blister card that has 24 “active” pink softgel capsules (with hormones) with “WC” printed on the outer shell in white to be taken for 24 days, followed by four maroon softgel capsules (without hormones) also imprinted with “WC” on one side to be taken for the next four days.
“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 FDA said.
Allegan is notifying customers and is arranging for the return of all recalled sample pack product with the lot #5620706 Exp. May 2019.
Consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.
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