Haloperidol Decanoate Injection
FDA Recall NDC 63323-471
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Haloperidol Decanoate (NDC 63323-471). A significant event, classified as Class III, was initiated on Apr 07, 2016 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result."
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 III Terminated
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Apr 07, 2016
Apr 20, 2016
48,210 units
Recall Profile & Regulatory Data
Event ID
73652
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 07, 2016
Product Description
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Batch or Lot Expiration Information
Lot# : 6111080, Exp. 01/2017
Affected Packages Involved in this Recall
63323-469-01Product
63323-469-05Product
63323-471-01Product
63323-471-05Product
Class III Terminated
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Apr 14, 2014
Nov 19, 2014
216,517 vials
Recall Profile & Regulatory Data
Event ID
68019
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Mar 08, 2016
Product Description
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Batch or Lot Expiration Information
Lot# Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
Affected Packages Involved in this Recall
63323-469-01Product
63323-469-05Product
63323-471-01Product
63323-471-05Product
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.
