FDA Drug recall D-1684-2012
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured…
- FDA Drug
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured… by Bracco Diagnostics, citing GMP deviation; Sr-82 levels exceeded alert limit specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1684-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-01 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bracco Diagnostics |
| Distribution | US |
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
GMP deviation; Sr-82 levels exceeded alert limit specification
Identifiers
| ndc | 0270-0091-01 |
|---|---|
| code_info | Lot numbers 09101-121251 and 09101-121391 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1684-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.