Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Isovue -300 (Iopamidol) Injection 61% Prefilled Recalled by Bracco Diagnostic Inc Due to Presence of Particulate Matter; fibers identified as cellulose...

Date: November 21, 2012
Company: Bracco Diagnostic Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bracco Diagnostic Inc directly.

Affected Products

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.

Quantity: 5736 syringes (573.6 boxes)

Why Was This Recalled?

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bracco Diagnostic Inc

Bracco Diagnostic Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report