Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Multihance Multipack (gadobenate dimeglumine) injection Recalled by Bracco Diagnostics Inc Due to Lack of Assurance of Sterility; Product recalled due...
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 Diagnostics Inc directly.
Affected Products
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.
Quantity: 4,870 Vials
Why Was This Recalled?
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bracco Diagnostics Inc
Bracco Diagnostics Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report