Janssen Pharmaceuticals has issued a voluntary recall for three lots of ORTHO-NOVUM tablets. The packages had the wrong instructions for the Veridate® dispenser included in them.
ORTHO-NOVUM® (norethindrone/ethinyl estradiol) is a contraceptive. It is used as birth control, to prevent pregnancy, and at times used as hormonal treatment for severe acne.
ORTHO-NOVUM® pill packs contain 28 pills with active medication. 21 have active medication/hormones, and 7 pills are inert reminder pills.
The potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that the pills would be taken in the incorrect order.
That could be harmless and still provide an adequate dose. However, the other risk is that the inactive “reminder” pill would be taken on days that the active pill is necessary. This could lead to breakthrough bleeding and, in a case of active ovulation, could lead to unintended pregnancy.
The lots with the inaccurate patient instructions were distributed only in the United States, to wholesalers, distributors, and pharmacies. Janssen Pharmaceuticals have already sent out letters and notifications to return the affected products.
Consumers with ORTHO-NOVUM® product from the affected lots can get the correct instructions for the Veridate® dispenser pack at https://www.janssen.com/us/our-products. If they have any concerns about their treatment program, they can talk to their prescribing medical professional. Consumers should not stop taking the product and if they do miss a dose, they should follow the instructions included in the packet for missing a dose.
The ORTHO-NOVUM® product itself remains safe and will be effective with the appropriate dispenser instructions.
No other ORTHO® contraceptive products beyond those three lots are impacted by this recall action.
Any questions regarding this recall can be addressed to Janssen Pharmaceuticals by phone: 1-800-526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 am to 8:00 pm ET. Consumers should contact their healthcare provider if they have experienced any problems that might be related to using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178
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