The Recall Desk
CriticalFDA (Drugs)·D-157-2013·Announced 2013-02-13

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard

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

Same manufacturer · Bracco Diagnostic Inc

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Same hazard · particulate matter

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