Janssen Recalls Some Oral Contraceptives With Instruction Errors

Nancy A. Melville

November 06, 2018

Janssen Pharmaceuticals has issued a voluntary recall involving two of its oral contraceptive formulations because the patient information inside the affected packages does not include appropriate instructions for the dispenser included in the products.

This could result in patients mistakenly taking an inactive "reminder" pill instead of an active pill, potentially leading to breakthrough bleeding or an unintended pregnancy.

The pharmacy-level recall, issued on November 2, affects one lot of Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) tablets and two lots of Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol) tablets.

Both of the birth control products are administered with the Veridate dispenser pack, which allows for the combination of active dose and inactive "reminder" pills to be taken in the proper order.

Under the appropriate order for the products for the prevention of pregnancy, women are instructed to take the 21 active pills containing hormones, which are peach-colored with the Ortho-Novum 1/35 and light-peach for Ortho-Novum7/7/7, daily for 3 weeks, followed by 1 week of the daily "reminder" pills (without hormones), which are green in both products.

In its recall notice posted on the US Food and Drug Administration website, Janssen noted that "the Ortho-Novum product itself remains safe and effective for use with the appropriate dispenser instructions."

Janssen added that none of the company's other contraception products are affected by the recall, including Ortho Tri-Cyclen Lo, Ortho Tri-Cyclen, Ortho Micronor, and Ortho Cyclen.

The recall only applies to products in the United States, which were distributed to wholesalers, distributors, and pharmacies. Sellers have been notified by a recall letter.

Consumers with Ortho-Novum product from the affected lots can access the correct instructions for the Veridate dispenser pack on the Janssen website and talk to their prescribing medical professional if they have any concerns, the company says. Janssen can also be reached at 1-800-526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 AM to 8:00 PM ET.

Women who miss a dose are advised to continue taking the product and follow the correct packaging instructions.

Details on the three lots affected by the recall are as follows.

Product Description NDC Number (carton) NDC Number (pouch) Lot No. Expiration Date

Ortho-Novum  1/35

50458-176-06 50458-176-28 18BM114 03/2020
Ortho-Novum 7/7/7 50458-178-06 50458-178-28 18CM120 03/2020
Ortho-Novum 7/7/7 50458-178-12 50458-178-12 18BM110 03/2020

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