Drug 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).
D-157-2013
Product summary
- Event
- Event 63765
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5483 syringes (548.3 boxes)
- Official record key
drug-enforcement:D-157-2013
Official wording
Reason: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Code information: Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter