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 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.
Lot numbers, UPCs & expiration codes
Lot #: a) 18CM120, Exp 03/2020; b) 18BM110, 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-0218-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 23, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- a) 3,956 cartons; b) 1 carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Janssen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0218-2019, 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 #: a) 18CM120, Exp 03/2020; b) 18BM110, Exp. 03/2020
- Postal code
- 08560
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0218-2019
- Classification
- Class II
- Recalling firm
- Janssen Pharmaceuticals, Inc.
- Product quantity
- a) 3,956 cartons; b) 1 carton
- 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 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2018