Drug 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
D-1684-2012
Product summary
- Event
- Event 62866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 generators
- Official record key
drug-enforcement:D-1684-2012
Official wording
Reason: GMP deviation; Sr-82 levels exceeded alert limit specification
Code information: Lot numbers 09101-121251 and 09101-121391
Distribution pattern: Nationwide and United Kingdom
Derived failure modes
-
Manufacturing or process control
GMP deviation