Three Lots of Ortho-Novum Recalled
November 2, 2018 – Janssen Pharmaceuticals has announced a voluntary recall of one lot of its Ortho-Novum® 1/35 (norethindrone/ethinyl estradiol) tablets, as well as two lots of Ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol) tablets to the pharmacy level. Affected lots do not contain the appropriate patient information on the use of the Veridate® dispenser.
Ortho-Novum 7/7/7 and Ortho-Novum 1/35 are combined oral contraceptive products that contain progestin (norethindrone) and estrogen (ethinyl estradiol). Both products require that the patient take an active tablet for 21 days, followed by an inactive “reminder” tablet for seven days. A new course begins immediately after Day 28. The reminder tablets are green to distinguish them from active tablets, which are white for Ortho-Novum 7/7/7 and peach for Ortho-Novum 1/35.
Despite the color differences in inactive and active tablets, patients who do not receive correct information on how to use the Veridate dispenser could still take the tablets in the wrong order. If a patient takes an inactive pill on a day when they should take an active pill, it may lead to breakthrough bleeding or an unintended pregnancy. Patients can find correct instructions for the Veridate dispenser by navigating to the Ortho-Novum 7/7/7 and Ortho-Novum 1/35 listings at:
Patients should continue taking their Ortho-Novum as prescribed, and address any questions regarding their medication or adverse effects to their prescriber. For questions about the recall, patients can reach Janssen Pharmaceuticals by phone at 1-800-526-7736, Monday through Friday, 9:00 am to 8:00 pm ET.
Further recall details can be found at:
Benecard Central Fill experienced minimal impact from the recall.