Recalls / Class II
Class IID-1684-2012
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
- Brand name
- Cardiogen-82
- Generic name
- Rubidium Chloride Rb-82
- Active ingredient
- Rubidium Chloride Rb-82
- Route
- Intravenous
- NDC
- 0270-0091
- FDA application
- NDA019414
- Affected lot / code info
- Lot numbers 09101-121251 and 09101-121391
Why it was recalled
GMP deviation; Sr-82 levels exceeded alert limit specification
Recalling firm
- Firm
- Bracco Diagnostics Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 54 generators
- Distribution pattern
- Nationwide and United Kingdom
Timeline
- Recall initiated
- 2012-06-01
- FDA classified
- 2012-09-21
- Posted by FDA
- 2012-10-03
- Terminated
- 2013-03-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1684-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.