Class II
Terminated
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.
- Company
- Bracco Diagnostics Inc
- Recall Initiated
- April 16, 2012
- Posted
- September 5, 2012
- Recall Number
- D-1665-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,870 Vials
- Firm Location
- Monroe Township, NJ, United States
Reason for Recall
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Distribution
Nationwide
Lot / Code Info
Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
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