Nalbuphine Hydrochloride Injection, Solution
FDA Recall NDC 0409-1464
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 Nalbuphine Hydrochloride (NDC 0409-1464). A significant event, classified as Class II, was initiated on Nov 21, 2012 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured."
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
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Nov 21, 2012
Dec 26, 2012
145,400 vials
Recall Profile & Regulatory Data
Event ID
63884
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Jun 03, 2014
Product Description
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Batch or Lot Expiration Information
Lot# : 11-293-DK, Exp 05/01/13
Affected Packages Involved in this Recall
0409-1463-71Product
0409-1463-01Product
0409-1465-71Product
0409-1465-01Product
0409-1464-61Product
0409-1464-01Product
0409-1467-61Product
0409-1467-01Product
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.
