Drug 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.
D-0217-2019
Product summary
- Event
- Event 81289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,777 cartons
- Official record key
drug-enforcement:D-0217-2019
Official wording
Reason: Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Code information: Lot # 18BM114, Exp. 03/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect