Drug recall D-1684-2012

Class II Terminated reported Oct 3, 2012

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

Lots and codes

Lot numbers 09101-121251 and 09101-121391

Recall details

Recalling firm
Bracco Diagnostics Inc, Princeton, NJ
Quantity
54 generators
Distribution
Nationwide and United Kingdom
Type
Voluntary: Firm initiated
Recall initiated
June 1, 2012
Terminated
March 18, 2013

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