Bracco Diagnostic Inc recalls Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125
Recalled February 13, 2013 · FDA recall D-157-2013 · Bracco Diagnostic
Hazard
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl · FDA Class I
Units
5483 syringes (548.3 boxes)
Sold at
Nationwide.
Description
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Product
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
Manufacturer(s)
Bracco Diagnostic Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →