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.
Recall initiated: 20181023
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated