Bracco Diagnostics Inc recalls CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride
Recalled October 3, 2012 · FDA recall D-1684-2012 · Bracco Diagnostics
Hazard
GMP deviation; Sr-82 levels exceeded alert limit specification · FDA Class II
Units
54 generators
Sold at
Nationwide and United Kingdom
Description
GMP deviation; Sr-82 levels exceeded alert limit specification
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
Manufacturer(s)
Bracco Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →