Status
Terminated
Drug Enforcement D-158-2013
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Classification
Class I
Report Date
February 13, 2013
Termination Date
July 6, 2015
Product Information
- 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.
- Product quantity
- 5736 syringes (573.6 boxes)
- Reason for recall
- Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Bracco Diagnostic Inc
- Address
-
259 Prospect Plains Road, Building H
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-158-2013
- Event ID
- 63765
- Recall initiation date
- November 21, 2012
- Center classification date
- February 7, 2013
- Code info
- Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
- More code info
- —