Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Man...
FDA Recall #D-158-2013 — Class I — November 21, 2012
Product Description
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.
Reason for Recall
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Recalling Firm
Bracco Diagnostic Inc — Monroe Township, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
5736 syringes (573.6 boxes)
Distribution
Nationwide.
Code Information
Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated