drugs Class I Updated 2013-02-13

Bracco Diagnostic Inc recalls Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL

Recalled 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).

Hazard / Issue

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
View official government recall

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