Unsafe Syringes

Janssen® Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. issues recall of Invega® Sustenna® because syringes can easily crack.

Janssen® Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of the 234 mg strength INVEGA® SUSTENNA® (paliperidone palmitate) Extended-Release Injectable Suspension listed below. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. No other products marketed by Janssen including other strengths of this product are impacted by this recall. Clinical trial supplies of the drug product are not impacted.

Recalled Products:

INVEGA® SUSTENNA® (paliperidone palmitate 234 mg) Extended-Release Injectable Suspension (TRADE)

• NDC: 50458-564-01
• Lot Number and Expiry: 9IBK000 (09/2011), 9IBK002 (09/2011), 9IBK003 (12/2011), 9IBK004 (02/2012), 9JBK005 (05/2012), 9IBK005 (05/2012), 9IBK001 (12/2012)

INVEGA® SUSTENNA® (paliperidone palmitate 234 mg) Extended-Release Injectable Suspension (SAMPLES NOT FOR SALE)

• NDC: 50458-564-03
• Lot Number and Expiry: 9JBK000 (08/2012), 9JBK001 (08/2012), 9IBK000 (12/2011)

Dates of Distribution: 3/16/2010 to the date of receipt of this letter.

Reason for Recall:

This voluntary recall is initiated after detection that some of the pre-filled syringes of the 234 mg strength can contain a crack in the syringe barrel. The crack is completely covered by the label and is not detectable by the user. Only the 234 mg strength is impacted.

Potential Health Hazard:

To date, there have been no reports of any adverse events of infection associated with the identified batches since product launch and no reports of product complaints of leakage associated with cracked syringe barrels.