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).
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