TITUSVILLE, N.J. — Janssen Pharmaceuticals Inc. is recalling certain birth control products because the instructions in some boxes do not match the products they are for.
According to the FDA, Janssen Pharmaceuticals is voluntarily 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 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 potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that 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, said the FDA.
The three lots affected by this recall are:
Product Description: ORTHO-NOVUM® 1/35, NDC Number (carton): 50458-176-06, NDC Number (pouch): 50458-176-28, Lot No.: 18BM114, Expiration Date: 03/2020
Product Description: ORTHO-NOVUM® 7/7/7, NDC Number (carton): 50458-178-06, NDC Number (pouch): 50458-178-28, Lot No.: 18CM120, Expiration Date:03/2020
Product Description: ORTHO-NOVUM® 7/7/7, NDC Number (carton): 50458-178-06, NDC Number (pouch): 50458-178-28, Lot No.: 18BM110, Expiration Date: 03/2020
Learn more about the recall here.