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.
Reported: February 13, 2013 Initiated: November 21, 2012 #D-158-2013
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
Details
- Recalling Firm
- Bracco Diagnostic Inc
- Units Affected
- 5736 syringes (573.6 boxes)
- Distribution
- Nationwide.
- Location
- Monroe Township, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bracco Diagnostic Inc. Units affected: 5736 syringes (573.6 boxes).
Why was this product recalled? ▼
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 13, 2013. Severity: Critical. Recall number: D-158-2013.
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