Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARDIOGEN-82 (Rubidium Rb 82 Generator) Recalled by Bracco Diagnostics Inc Due to GMP deviation; Sr-82 levels exceeded alert limit specification
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
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
Quantity: 54 generators
Why Was This Recalled?
GMP deviation; Sr-82 levels exceeded alert limit specification
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