Dobutamine In Dextrose Injection, Solution
FDA Recall NDC 0409-1100
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 Dobutamine In Dextrose (NDC 0409-1100). A significant event, classified as Class II, was initiated on Apr 30, 2013 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Confirmed report of leaking in the primary container."
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: Confirmed report of leaking in the primary container.
Apr 30, 2013
Jun 12, 2013
44,748 bags
Recall Profile & Regulatory Data
Event ID
65225
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Oct 08, 2014
Product Description
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Batch or Lot Expiration Information
Lot# Lot 11-309-KL
Affected Packages Involved in this Recall
0409-2347-31Product
0409-2347-32Product
0409-2346-31Product
0409-2346-32Product
0409-3724-11Product
0409-3724-32Product
0409-0025-01Product
0409-0025-10Product
0409-0151-01Product
0409-0151-10Product
0409-1100-01Product
0409-1100-10Product
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.
