Bracco Recalls Isovue-300 Injection Syringes Due to Particulate Matter
Bracco Diagnostic Inc. is recalling specific lots of Isovue-300 Injection syringes because they contain particulate matter identified as cellulose and polyvinyl fibers.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Bracco Diagnostic Inc. is recalling 5,736 syringes (573.6 boxes) of Isovue-300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe. The product is prescription-only and was manufactured for Bracco Diagnostics Inc. by Nycomed GmbH in Germany.
The recall was initiated due to the presence of particulate matter in the product. The fibers were identified as cellulose and polyvinyl. The affected lots are 9K34572 (Exp 11/12), 0A43282 (Exp 01/13), and 0C56283 (Exp 03/13). The product was distributed nationwide.
Healthcare providers and patients should stop using the affected syringes and contact Bracco Diagnostic Inc. for further instructions or a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Bracco Diagnostic Inc
- Category
- Drug — Injectable Contrast Media
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 9K34572
- Exp 11/12
- 0A43282
- Exp 01/13
- 0C56283
- Exp 03/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bracco Diagnostic Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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