Haloperidol Decanoate Injection
FDA Recall NDC 67457-409
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 67457-409). A significant event, classified as Class II, was initiated on Feb 18, 2015 by Mylan Institutional Llc. The reported reason for this action was: "Lack of Assurance of Sterility; due to leaking vials"
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
February 2015 Class II Recall: Lack of Assurance of Sterility; due to leaking vials
Recall Number
Class II Terminated
Lack of Assurance of Sterility; due to leaking vials
Feb 18, 2015
Apr 01, 2015
11,030 cartons (55,150 vials)
Recall Profile & Regulatory Data
Event ID
70564
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Institutional LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 23, 2017
Product Description
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Batch or Lot Expiration Information
Lot# Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16
Affected Packages Involved in this Recall
67457-410-00Product
67457-410-13Product
67457-409-00Product
67457-409-13Product
February 2015 Class II Recall: Lack of Assurance of Sterility; due to leaking vials
Recall Number
Class II Terminated
Lack of Assurance of Sterility; due to leaking vials
Feb 18, 2015
Apr 01, 2015
2,523 cartons (25,936 vials)
Recall Profile & Regulatory Data
Event ID
70564
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Institutional LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 23, 2017
Product Description
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Batch or Lot Expiration Information
Lot# Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16
Affected Packages Involved in this Recall
67457-410-00Product
67457-410-13Product
67457-409-00Product
67457-409-13Product
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.
