Allergan Voluntary Recalls One Lot Of Taytulla Softgel Capsules In U.S.

(RTTNews) - Allergan plc (AGN) said it has issued a voluntary recall in the U.S. market of one lot 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.

The lot number for the recalled Taytula softgel capsules is #5620706, with expiry date of May 2019. 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.

Allergan said that through a physician report, it recently identified 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.

Allergan noted that 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. Patients having concerns regarding the possibility of an unintended pregnancy should consult their physician.

The company added that consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return.