Physician-Issued Oral Contraceptive Recalled

May 30th 2018

One lot of TAYTULLA Softgel capsules sample packs (1 mg/20mcg, 6x28 size) has been voluntarily recalled by Allergan.

One lot of TAYTULLA physicians sample packs (1 mg/20mcg, 6x28 size) has been voluntarily recalled by Allergan. The lot is identified as #5620706, expiring May 2019.

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is an oral contraceptive indicated for the prevention of pregnancy. Conducted with the knowledge of the FDA, the recall was issued due to capsules being placed out of sequence in the sample blister packs. Four placebo capsules were placed out of order in the packs, which were distributed nationwide to women through their physicians.

The erroneous placement would give consumers nonhormonal capsules for the first 4 days of the cycle, instead of active capsules. The sample packs include 28 capsules, of which 24 are active and intended to all be taken by women prior to the placebos.

According to the Allergan, oral contraceptive capsules taken out of sequence may place the user at risk for contraceptive failure, and unintended pregnancy. Reversing the capsule order in the affected lot may not be apparent to new or previous users of the product, which increases the likelihood of the capsules being taken out of order.

Allergan is notifying consumers by letter, and is arranging for all recalled sample packs to be returned through physicians. Consumers with questions about the recall should contact Allergen by phone at 800-678-1605, or speak with their physician or healthcare provider. Patients with concerns regarding the possibility of an unintendedpregnancyare being instructed to consult their physicians.

Reference

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules [news release]. Dublin, Ireland: May 29, 2018; PRNewswire. https://www.prnewswire.com/news-releases/allergan-issues-nationwide-voluntary-recall-of-taytulla-softgel-capsules-1mg20mcg-sample-packs-due-to-out-of-sequence-capsules-300655672.html. Accessed May 30, 2018.

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