(WPRI) — The maker of Ortho-Novum has issued a voluntary recall for three different lots of the birth control, the US Food and Drug Administration announced Tuesday.
Janssen Pharmaceuticals is 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 appropriate 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 breakthrough bleeding or an unintended pregnancy.
The three lots affected by this recall are:
|Product Description||NDC Number (carton)||NDC Number (pouch)||Lot No.||Expiration Date|
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).
The company said consumers with ORTHO-NOVUM® product from the affected lots can access 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 should not stop taking the product 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.