FDA Recall D-157-2013

Bracco Diagnostic Inc · Monroe Township, NJ

Class I — life-threatening Terminated 957 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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).

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

Quantity: 5483 syringes (548.3 boxes)

Reason for recall

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Recall record

Recall number: D-157-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide.
Recall initiated: 2012-11-21
Classified by FDA Center: 2013-02-07
FDA published: 2013-02-13
Terminated: 2015-07-06
Recalling firm: Bracco Diagnostic Inc
Firm location: Monroe Township, NJ

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