Bracco Diagnostics Inc recalls Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For
Recalled September 5, 2012 · FDA recall D-1665-2012 · Bracco Diagnostics
Hazard
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. · FDA Class II
Units
4,870 Vials
Sold at
Nationwide
Description
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
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.
Manufacturer(s)
Bracco Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →