Cardiogen-82 (Bracco Diagnostics) – Sr-82 level deviation (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Bracco Diagnostics Inc
Lot Codes / Batch Numbers
Lot numbers 09101-121251 and 09101-121391
Products Sold
Lot numbers 09101-121251 and 09101-121391
Bracco Diagnostics Inc is recalling CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogeni due to GMP deviation; Sr-82 levels exceeded alert limit specification. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GMP deviation; Sr-82 levels exceeded alert limit specification
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026