CLASS II Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report
Cardiogen-82 (Rubidium Rb 82 Generator), 140 millicurie recalled
Bracco Diagnostics is recalling Cardiogen-82 (Rubidium Rb 82 Generator), 140 millicurie, distributed nationwide in the US. The recall was initiated on 1 Jun 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1684-2012
- FDA event ID
- 62866
- Recalling firm
- Bracco Diagnostics, Princeton, NJ
- Brand
- Cardiogen-82
- Manufacturer
- Bracco Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2012
- FDA classified
- 21 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
Timeline
| 1 Jun 2012 | Recall initiated by company | |
| 21 Sep 2012 | Classified by FDA | +112 days |
| 3 Oct 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP deviation; Sr-82 levels exceeded alert limit specification
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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
Where it was distributed
Nationwide and United Kingdom
Questions about this recall
Why was it recalled?
GMP deviation; Sr-82 levels exceeded alert limit specification
Which lots are affected?
Lot numbers 09101-121251 and 09101-121391
Where was it sold?
Nationwide and United Kingdom
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS III | Tagitol V Barium Sulfate Suspension (40% w/v recalled | Bracco Diagnostics | Potency & Assay | Nationwide |
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| Drug | CLASS II | Multihance Multipack (gadobenate dimeglumine) injection recalledMultihance | Bracco Diagnostics | Sterility | Nationwide |