D-158-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 13, 2013
- Initiation Date
- November 21, 2012
- Termination Date
- July 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5736 syringes (573.6 boxes)
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
Distribution Pattern
Nationwide.
Code Information
Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13