FDA-Drug2012-10-03Class II
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
Bracco Diagnostics Inc
Hazard
GMP deviation; Sr-82 levels exceeded alert limit specification
Sold states
Nationwide and United Kingdom
Affected count
54 generators
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1684-2012Don't want to check this manually?
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