FDA-Drug2013-02-13Class I
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
Bracco Diagnostic Inc
Hazard
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Sold states
Nationwide.
Affected count
5736 syringes (573.6 boxes)
Manufactured in
259 Prospect Plains Road, Building H, Monroe Township, NJ, United States
Products
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-158-2013Don't want to check this manually?
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