FDAFDA · Food and drugs·Recall number D-0217-2019
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 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 # 18BM114, Exp. 03/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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