If your email program has trouble displaying this email, view it as a web page

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, 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 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. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician. **  If you did not subscribe to the FDA Recalls, Market Withdrawals and Safety Alerts subscription you may unsubscribe from this list. For additional information pertaining to this message, please click the link at the beginning of this bulletin.

U.S. Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Privacy Policy | www.fda.gov Manage Preferences or Unsubscribe from this List | Unsubscribe from all Email Lists