The makers of Ortho Novum is voluntarily recalling one lot of ORTHO -NOVUM 1/35 AND two lots of ORTHO-NOVUM 7/7/7 tablets. The pills are safe, but some lots lack appropriate instructions.
Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM® 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM® 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the pharmacy level.
The patient information provided inside affected packages of ORTHO-NOVUM® does not include the appropriate instructions for the Veridate® dispenser.
The ORTHO-NOVUM® product itself remains safe and effective for use with the appropriate dispenser instructions. 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 recall affects the products below.
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.
Photo Credit: Janssesn