Drug 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.
D-158-2013
Product summary
- Event
- Event 63765
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5736 syringes (573.6 boxes)
- Official record key
drug-enforcement:D-158-2013
Official wording
Reason: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Code information: Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter