FDA-Drug2012-09-05Class II
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.
Bracco Diagnostics Inc
Hazard
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Sold states
Nationwide
Affected count
4,870 Vials
Manufactured in
259 Prospect Plains Rd., Building H, Monroe Township, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1665-2012Don't want to check this manually?
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