FDAClass IIOctober 3, 2012

Cardiogen-82 recall

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for…

Why was Cardiogen-82 recalled?

GMP deviation; Sr-82 levels exceeded alert limit specification

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 09101-121251 and 09101-121391

Product
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for…
Recalling firm
Bracco Diagnostics Inc
Quantity
54 generators
Distribution
Nationwide and United Kingdom
Recall date
October 3, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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