Multihance Injection, Solution
FDA Recall NDC 0270-5264
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 0270-5264). A significant event, classified as Class II, was initiated on Apr 16, 2012 by Bracco Diagnostics Inc. The reported reason for this action was: "Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage."
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
April 2012 Class II Recall: Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Recall Number
Class II Terminated
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Apr 16, 2012
Sep 05, 2012
4,870 Vials
Recall Profile & Regulatory Data
Event ID
62735
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bracco Diagnostics Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 13, 2013
Product Description
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
Batch or Lot Expiration Information
Lot# : a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Affected Packages Involved in this Recall
0270-5264-16Product
0270-5264-17Product
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.
