3 lots of Ortho-Novum birth control recalled for improper dispenser instructions

Product is safe for use with right instructions
Posted: 7:57 PM, Nov 06, 2018
Updated: 2018-11-07 07:54:11-05

Janssen Pharmaceuticals has issued a voluntary recall for three different lots of the birth control, according to the U.S. Food and Drug Administration.

Ortho-Novum 1/35, or norethindrone/ethinyl estradiol, tablets and two lots of Ortho-Novum 7/7/7, or norethindrone/ethinyl estradiol, tablets were recalled. 

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The recall includes:
Ortho-Novum 1/35: NDC Number on carton, 50458-176-06; NDC Number on pouch, 50458-176-28; Lot No. 18BM114; expiration date, March 2020
Ortho-Novum 7/7/7: NDC Number on carton, 50458-178-06; NDC Number on pouch, 50458-178-28; Lot No. 18CM120; expiration date, March 2020
Ortho-Novum 7/7/7: NDC Number on carton, 50458-178-12; NDC Number on pouch, 50458-178-12; Lot No. 18BM110; expiration date, March 2020

The company said that the patient information inside recalled packages does not include appropriate instructions for the Veridate dispenser.

The product, however, remains safe for use with appropriate dispenser instructions, the company said.

Consumers using the recalled instructions could take the pills in the incorrect order or could take an inactive "reminder" pill instead of an "active" pill, which could lead to breakthrough bleeding or an unintended pregnancy.

Women should continue to take the 21 "active" pills, with hormones, for three weeks followed by the one week of green "reminder" pills, without hormones, the company added. 
Consumers with questions can contact Janssen at 1-800-526-7736 Monday through Friday from 9 a.m. to 8 p.m. ET.