FDA recall D-157-2013

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2012-11-21

Report date

2013-02-13

Termination date

2015-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-157-2013