Reported Oct 3, 2012 · Terminated
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride…
Bracco Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bracco Diagnostics Inc · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82
- Manufactured for
Bracco Diagnostics Inc. PrincetonNJ 08543 by Medi-PhysicsInc. South PlainfieldNJ 07080NDC 0270-0091-01
- Lot codes and dates
- Lot numbers 09101-121251 and 09101-121391
- Amount recalled
- 54 generators
Where it was sold
- Nationwide
Why it was recalled
GMP deviation; Sr-82 levels exceeded alert limit specification
This product could cause temporary or reversible health problems — stop using it.
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