🔍 RecallPedia

Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.

Class I - Dangerous
💊 Drugs Recalled: April 16, 2012 Bracco Diagnostics Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
  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 Diagnostics Inc
Reason for Recall:
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.

Product Codes/Lot Numbers:

Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1665-2012

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