Isovue -370 recall: Particulate Matter
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…
Why was Isovue -370 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 #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
- 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…
- Recalling firm
- Bracco Diagnostic Inc
- Quantity
- 5483 syringes (548.3 boxes)
- Distribution
- Nationwide.
- Recall date
- February 13, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)