Why it was recalled
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 18BM114, Exp. 03/2020
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0217-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 23, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- 1,777 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Janssen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0217-2019, exactly as published.
Show all FDA fields
- City
- Titusville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81289
- Address
- 1125 Trenton-Harbourton Rd.
- Code information
- Lot # 18BM114, Exp. 03/2020
- Postal code
- 08560
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0217-2019
- Classification
- Class II
- Recalling firm
- Janssen Pharmaceuticals, Inc.
- Product quantity
- 1,777 cartons
- Termination date
- Oct 30, 2019
- Reason for recall
- Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2018