Cardiogen-82 Injection, Solution
FDA Recall NDC 0270-0091
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cardiogen-82 (NDC 0270-0091). A significant event, classified as Class II, was initiated on Jun 01, 2012 by Bracco Diagnostics Inc. The reported reason for this action was: "GMP deviation; Sr-82 levels exceeded alert limit specification"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
June 2012 Class II Recall: GMP deviation; Sr-82 levels exceeded alert limit specification
Recall Number
Class II Terminated
GMP deviation; Sr-82 levels exceeded alert limit specification
Jun 01, 2012
Oct 03, 2012
54 generators
Recall Profile & Regulatory Data
Event ID
62866
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bracco Diagnostics Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and United Kingdom
Termination Date
Mar 18, 2013
Product Description
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
Batch or Lot Expiration Information
Lot# Lot numbers 09101-121251 and 09101-121391
Affected Packages Involved in this Recall
0270-0091-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
