FDAFDA · Food and drugs·Recall number D-0218-2019
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.
Published November 14, 2018 · Recall initiated: October 23, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: a) 18CM120, Exp 03/2020; b) 18BM110, Exp. 03/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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