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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

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.
Recall Number D-1665-2012
Classification Class II
Code Info Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Product Distributed Qty 4,870 Vials
Reason For Recall Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Event Detail

Event Id 62735
Product Type Drugs
Status Ongoing
Recalling Firm Bracco Diagnostic Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide