FDA recall D-1514-2014

Janssen Pharmaceuticals, Inc. · Class II · drug

Product

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

Nationwide

Key facts

Status
Terminated
Initiation date
2013-09-11
Report date
2014-08-13
Termination date
2015-01-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Titusville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1514-2014