Morphine Sulfate Injection, Solution
FDA Recall NDC 0409-3814
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 Morphine Sulfate (NDC 0409-3814). A significant event, classified as Class II, was initiated on Aug 28, 2012 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial"
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: Loose crimp applied to the fliptop vial
Aug 28, 2012
May 08, 2013
26,100 vials
Recall Profile & Regulatory Data
Event ID
64720
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 18, 2014
Product Description
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Batch or Lot Expiration Information
Lot# Lot 15-065-DK, Exp 1SEP2013
Affected Packages Involved in this Recall
0409-3814-11Product
0409-3814-12Product
0409-3815-11Product
0409-3815-12Product
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.
