TITUSVILLE, N.J. – Janssen Pharmaceuticals has called for a voluntary recall of three lots of birth control pills because they did not include the correct instructions in their packages.
At stake are one lot of Ortho-Novum 1/35 and two lots of Ortho-Novum 7/7/7.
Janssen Pharmaceuticals said information inside the affected packages did not include the appropriate instructions for the dispenser. The risk without proper instructions is that consumers may take the pills in the wrong order or take a "reminder" pill instead of an "active" pill. This could result in spotting or bleeding, or an unintended pregnancy.
Janssen Pharmaceuticals said the product itself is safe with appropriate instructions, and that women should continue their regimen of 21 "active" pills with seven "reminder" pills.
The lots affected include:
Product Description NDC # (carton) NDC # (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
Wholesalers, distributors and pharmacies have been notified to return the affected products.
Consumers with the pills from the affected lots can access the correct instructions at https://www.janssen.com/us/our-products.