Risperdal Consta Kit
FDA Recall NDC 50458-307
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Risperdal Consta (NDC 50458-307). A significant event, classified as Class II, was initiated on Sep 11, 2013 by Janssen Pharmaceuticals, Inc.. The reported reason for this action was: "Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Sep 11, 2013
Aug 13, 2014
70,495 kits
Recall Profile & Regulatory Data
Event ID
66261
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Janssen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 23, 2015
Product Description
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Batch or Lot Expiration Information
Lot# Vial - 4212AAP1, Kit - 309316, Exp. 07/15
Affected Packages Involved in this Recall
50458-309-11Product
50458-309-01Product
50458-306-11Product
50458-306-01Product
50458-307-11Product
50458-307-01Product
50458-308-11Product
50458-308-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
