(WTVY) — A pharmaceutical company is recalling birth control pills, due to incorrect packaging that could lead to bleeding or even unintended pregnancy.
Janssen Pharmaceuticals, Inc. is recalling one lot of ORTHO-NOVUM® 1/35 Tablets and two lots of ORTHO-NOVUM® 7/7/7 Tablets.
The instruction included with the dispensers is not correct and could lead to women taking the pills in the wrong order.
The FDA says the pills themselves are safe and effective for use with the appropriate dispenser instructions.
The three lots affected by this recall are:
Product Description NDC Number (carton) NDC Number (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
The products were distributed in the U.S. to wholesalers, distributors and pharmacies, and they have been notified by recall letter to return affected products.
Consumers with pills from the affected lots can access the correct instructions for the dispenser pack at https://www.janssen.com/us/our-products and talk to their prescribing medical professional if they have any concerns.
Consumers with questions regarding this recall can contact Janssen via phone on: 1-800-526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 am to 8:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.