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.
Reason for recall: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Recall initiated: 20121121
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated