Drug recall D-157-2013

Class I Terminated reported Feb 13, 2013

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

Lots and codes

Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13

Recall details

Recalling firm
Bracco Diagnostic Inc, Monroe Township, NJ
Quantity
5483 syringes (548.3 boxes)
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
November 21, 2012
Terminated
July 6, 2015

Related products