CARDIOGEN-82 — Class II drug recall D-1684-2012
Terminated recall by Bracco Diagnostics Inc, reported 2012-10-03, distributed nationwide. GMP deviation; Sr-82 levels exceeded alert limit specification
| Recall number | D-1684-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostics Inc, Princeton, NJ, United States |
| Recall initiated | 2012-06-01 |
| Classified | 2012-09-21 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 54 generators |
| Reason classes | cgmp |
| NDC | 00270-0091, 00270-0091-01 |
| Lot numbers | 09101-121251, 09101-121391 |
Product
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
Reason for recall
GMP deviation; Sr-82 levels exceeded alert limit specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1684-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.