drugs Class II Updated 2012-10-03

Bracco Diagnostics Inc recalls CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx

Recalled 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

Hazard / Issue

GMP deviation; Sr-82 levels exceeded alert limit specification

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers 09101-121251 and 09101-121391
View official government recall

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