🔍 RecallPedia

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).

Class I - Dangerous
💊 Drugs Recalled: November 21, 2012 Bracco Diagnostic Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bracco Diagnostic Inc
Reason for Recall:
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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).

Product Codes/Lot Numbers:

Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-157-2013

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