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
Reason for recall: GMP deviation; Sr-82 levels exceeded alert limit specification
Recall initiated: 20120601
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated