Multihance Injection, Solution
FDA Recall NDC 0270-5164
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 Multihance (NDC 0270-5164). A significant event, classified as Class III, was initiated on Apr 16, 2012 by Bracco Diagnostics Inc. The reported reason for this action was: "Short Fill: The product is being recalled due to a potential underfill of the affected 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
Class III Terminated
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Apr 16, 2012
Sep 05, 2012
47,750 vials
Recall Profile & Regulatory Data
Event ID
62636
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bracco Diagnostics Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 08, 2013
Product Description
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
Batch or Lot Expiration Information
Lot# Lot S1P272A Expiry Date: December 2014
Affected Packages Involved in this Recall
0270-5164-12Product
0270-5164-13Product
0270-5164-14Product
0270-5164-15Product
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.
