Isovue -300 recall: Particulate Matter
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ…
Why was Isovue -300 recalled?
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
- Product
- Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ…
- Recalling firm
- Bracco Diagnostic Inc
- Quantity
- 5736 syringes (573.6 boxes)
- Distribution
- Nationwide.
- Recall date
- February 13, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)