Home / Recalls / Janssen Pharmaceuticals, Inc. / D-1063-2015

D-1063-2015 Class II Terminated

Recalled by Janssen Pharmaceuticals, Inc. — Titusville, NJ

Recall Details

Product Type
Drugs
Report Date
May 20, 2015
Initiation Date
April 29, 2015
Termination Date
July 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,861 cartons/6 blister units (28 tablets) each

Product Description

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

Reason for Recall

Subpotent Drug

Distribution Pattern

Nationwide and Canada

Code Information

Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada)

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-0218-2019 Class II — Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0. (October 23, 2018)
  • D-1514-2014 Class II — Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Jans (September 11, 2013)