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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 62866
Product Type Drugs
Status Ongoing
Recalling Firm Bracco Diagnostics Inc
City Princeton
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and United Kingdom

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot numbers 09101-121251 and 09101-121391 Class II GMP deviation; Sr-82 levels exceeded alert limit specification 54 generators D-1684-2012