drugs Class I Updated 2013-02-13

Bracco Diagnostic Inc recalls Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL

Recalled 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.

Hazard / Issue

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
View official government recall

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