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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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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
Distribution Pattern Nationwide

Product Detail

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