Bracco Diagnostic Inc recalls Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Di
Recalled February 13, 2013 · FDA recall D-158-2013 · Bracco Diagnostic
Hazard
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl · FDA Class I
Units
5736 syringes (573.6 boxes)
Sold at
Nationwide.
Description
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Product
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.
Manufacturer(s)
Bracco Diagnostic Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →