Product: 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.
Reason for recall: Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Recall initiated: 20120416
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated