FDA Recall D-158-2013
Bracco Diagnostic Inc · Monroe Township, NJ
Class I — life-threatening Terminated 957 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Recall record
- Recall number
D-158-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide.
- Recall initiated
- 2012-11-21
- Classified by FDA Center
- 2013-02-07
- FDA published
- 2013-02-13
- Terminated
- 2015-07-06
- Recalling firm
- Bracco Diagnostic Inc
- Firm location
- Monroe Township, NJ