Taytulla Sample Packs Voluntarily Recalled
May 29, 2018 – Allergan has issued a voluntary recall of one lot of Taytulla® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample packs. The recall is due to capsules having been placed out of order in the packs.
The recall affects packs from Lot# 5620706, with an expiration date of May 2019.
A form of birth control, Taytulla requires patients to take 24 days of active capsules followed by four days of inactive placebo capsules. The four placebo capsules are intended to help patients stay in the habit of taking their medication on a daily basis.
Allergan became aware through a physician report that four placebo pills in a sample pack distributed through physicians’ offices were incorrectly marked as being for days 1-4. This error may not be apparent to either existing or new users of Taytulla. Taking the placebo pills during the first four days, rather than on days 25-28, may result in contraceptive failure and unintended pregnancies.
Patients who are concerned about unintended pregnancy due to taking placebo pills out of order should contact their physicians.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.