FDAFDA · Food and drugs·Recall number D-158-2013
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.
Published February 13, 2013 · Recall initiated: November 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bracco Diagnostic Inc
- Distributor
- Nationwide.
- Lot
- Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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