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

Recall Number: D-1514-2014

Firm: Janssen Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20140813

Initiation Date: 20130911

Termination Date: 20150123

Reason for Recall

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

Product Description

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