Home / Recalls / Janssen Pharmaceuticals, Inc. / D-1514-2014

D-1514-2014 Class II Terminated

Recalled by Janssen Pharmaceuticals, Inc. — Titusville, NJ

Recall Details

Product Type
Drugs
Report Date
August 13, 2014
Initiation Date
September 11, 2013
Termination Date
January 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,495 kits

Product Description

Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11

Reason for Recall

Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

Distribution Pattern

Nationwide

Code Information

Vial - 4212AAP1, Kit - 309316, Exp. 07/15

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-1063-2015 Class II — Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- coun (April 29, 2015)