Drug 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.
D-1665-2012
Product summary
- Event
- Event 62735
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,870 Vials
- Official record key
drug-enforcement:D-1665-2012
Official wording
Reason: Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Code information: Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility