Drug recall D-1665-2012
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.
Lots and codes
Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Recall details
- Recalling firm
- Bracco Diagnostics Inc, Monroe Township, NJ
- Quantity
- 4,870 Vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 16, 2012
- Terminated
- November 13, 2013
Related products
- MultiHance – drug information
- NDC 0270-5264 MultiHance · Gadobenate Dimeglumine 529 mg/mL · BRACCO DIAGNOSTICS INC