Recalls / Class II

Class IID-0218-2019

Product

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.

Affected lot / code info

Lot #: a) 18CM120, Exp 03/2020; b) 18BM110, 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

a) 3,956 cartons; b) 1 carton

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-0218-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.