Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto

FDA recall notice · announced November 14, 2018 · Janssen Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.

Reason for recall

Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # 18BM114, Exp. 03/2020
Quantity: 1,777 cartons
Status: Terminated
Products in this recall event:
- Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches ( (D-0218-2019)
- Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx onl (D-0217-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.