Recalls / Class II
Class IID-0217-2019
Product
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.
- Affected lot / code info
- Lot # 18BM114, Exp. 03/2020
Why it was recalled
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Recalling firm
- Firm
- Janssen Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1125 Trenton-Harbourton Rd., Titusville, New Jersey 08560
Distribution
- Quantity
- 1,777 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-10-23
- FDA classified
- 2018-11-06
- Posted by FDA
- 2018-11-14
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0217-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.