Bracco Recalls Isovue-370 Injection Syringes Due to Particulate Matter
Bracco Diagnostic Inc. is recalling specific lots of Isovue-370 injection syringes because they contain particulate matter, including 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
Bracco Diagnostic Inc. is recalling 5,483 syringes of Isovue-370 (Iopamidol) Injection 76% in prefilled power injector syringes. The recall covers specific lots with expiration dates ranging from November 2012 to May 2013. The product was distributed nationwide.
The recall was initiated due to the presence of particulate matter in the syringes. The fibers identified in the particulate matter are cellulose and polyvinyl. This is an FDA Class I recall, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
Healthcare providers and patients should stop using the affected syringes immediately. The source text does not specify the exact steps for returning the product or the specific contact information for the recall, but users should refer to the official FDA recall notice for detailed instructions on how to proceed.
The recalled product
- 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 Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
- Manufacturer
- Bracco Diagnostic Inc
- Category
- Drug — Injectable Contrast Agent
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 (11)
- Lot #: 9K37791
- Exp 11/12
- 9L40746
- Exp 12/12
- 0A43705
- Exp 01/13
- 0C57509
- 0C57521
- Exp 03/13
- 0E62913
- Exp 05/13
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.
See all 2 products in this recall →Related recalls
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