Janssen announced a voluntary recall of 1 lot of Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) and 2 lots of Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol) due to incorrect Veridate dispenser instructions.
Without proper instructions for the correct use of the Veridate dispenser pack, the patient may take the pills in the wrong order or may take an inactive “reminder” pill vs an “active” pill. This can lead to breakthrough bleeding or an unintended pregnancy. The affected lots are as follows:
- Ortho-Novum 1/35: Lot# 18BM114, Exp 03/2020
- Ortho-Novum 7/7/7: Lot# 18CM120, Exp 03/2020
- Ortho-Novum 7/7/7: Lot# 18BM110, Exp 03/2020
Ortho-Novum 1/35 and Ortho-Novum 7/7/7 are oral contraceptives indicated to prevent pregnancy in women who choose to use the product as a method of contraception. The Company stated in a press release that the Ortho-Novum product itself remains safe and effective for use with the appropriate dispenser instructions. The appropriate instructions for the Veridate dispenser pack can be found here.
The recall does not affect Ortho Tri-Cyclen Lo, Ortho Tri-Cyclen, Ortho Micronor, and Ortho Cyclen. Any adverse reactions or quality problems associated with the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
For more information call (800) 526-7736 or visit Janssen.com.