TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules
[Posted 05/29/2018]
AUDIENCE: Patient, Pharmacy, Health Professional
ISSUE: Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA and the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
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.
BACKGROUND: This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. The TAYTULLA pill pack is 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 4 maroon softgel capsules (without hormones) also imprinted with “WC” on one side to be taken for the next four days.
RECOMMENDATION: Patients who have the sample pack product with the lot #5620706 Exp. May 2019, should notify their healthcare provider to arrange a return or if they have questions. Patients with questions regarding this recall can contact Allergan by phone at 800-678-1605 8am-8pm EST Monday through Friday.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/29/2018 - Recall- FDA]
