Drug product
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 (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.
D-0218-2019
Product summary
- Event
- Event 81289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 3,956 cartons; b) 1 carton
- Official record key
drug-enforcement:D-0218-2019
Official wording
Reason: Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Code information: Lot #: a) 18CM120, Exp 03/2020; b) 18BM110, Exp. 03/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect