Drug Enforcement D-157-2013

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Status

Terminated

Classification

Class I

Report Date

February 13, 2013

Termination Date

July 6, 2015

Product Information

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).
Product quantity
5483 syringes (548.3 boxes)
Reason for recall
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Bracco Diagnostic Inc
Address
259 Prospect Plains Road, Building H

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-157-2013
Event ID
63765
Recall initiation date
November 21, 2012
Center classification date
February 7, 2013
Code info
Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
More code info
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