The maker of Ortho-Novum has issued a recall for three different lots of the birth control, the US Food and Drug Administration announced Tuesday.
Janssen Pharmaceuticals is voluntarily recalling one lot of Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) tablets and two lots of Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol) tablets. The company said the information inside the affected packages does not include the proper instructions for the Veridate dispenser.
The company said while the product itself remains safe, without the appropriate instructions the consumer could take the pills in the incorrect order (still receiving an effective dose) or could take an inactive “reminder” pill instead of an “active” pill which could lead to unintended pregnancy or breakthrough bleeding.
The three lots affected by this recall are:
- 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
The company said women should continue to take the 21 “active” pills (with hormones) (peach for ORTHO-NOVUM® 1/35; white, light-peach and peach for ORTHO-NOVUM® 7/7/7) for three weeks, followed by the one week of green “reminder” pills (without hormones).
Those with affected ORTHO-NOVUM® lots can find the correct instructions for the Veridate® dispenser pack at https://www.janssen.com/us/our-products and talk to their prescribing medical professional if they have any concerns.
Consumers are being advised to keep taking the products, and if they do miss a dose, they should follow the instructions included in the packet. Consumers with questions regarding this recall can contact Janssen via phone on: 1-800-526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 am to 8:00 pm ET.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.