Home / Recalls / Janssen Pharmaceuticals, Inc. / D-0218-2019

D-0218-2019 Class II Terminated

Recalled by Janssen Pharmaceuticals, Inc. — Titusville, NJ

Recall Details

Product Type
Drugs
Report Date
November 14, 2018
Initiation Date
October 23, 2018
Termination Date
October 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 3,956 cartons; b) 1 carton

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.

Reason for Recall

Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.

Distribution Pattern

Nationwide in the USA

Code Information

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

Other recalls by Janssen Pharmaceuticals, Inc.

  • D-0217-2019 Class II — Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Da (October 23, 2018)
  • D-1063-2015 Class II — Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- coun (April 29, 2015)
  • D-1514-2014 Class II — Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Jans (September 11, 2013)