Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC ...
FDA Recall #D-157-2013 — Class I — November 21, 2012
Product Description
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
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
5483 syringes (548.3 boxes)
Distribution
Nationwide.
Code Information
Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated