Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 2, 2018

Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules

(Taytulla Softgel Capsules—Allergen)
Discovery of out-of-sequence capsules prompts recall of oral contraceptive

Allergan issued a voluntary recall of one lot (#5620706, Expiry May-2019) of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 1 mg/20 mcg, 6 x 28 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. Specifically, the first four days of therapy had four nonhormonal placebo capsules instead of active capsules.

Oral contraceptive capsules that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversed 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.

The product was distributed Nationwide to healthcare providers.

Please refer here to the affected lot number as well as photographs of the affected product.