Status
Terminated
Drug Enforcement D-1684-2012
GMP deviation; Sr-82 levels exceeded alert limit specification
Classification
Class II
Report Date
October 3, 2012
Termination Date
March 18, 2013
Product Information
- Product description
- 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
- Product quantity
- 54 generators
- Reason for recall
- GMP deviation; Sr-82 levels exceeded alert limit specification
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and United Kingdom
Location & Firm
- Recalling firm
- Bracco Diagnostics Inc
- Address
-
107 College Rd E, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1684-2012
- Event ID
- 62866
- Recall initiation date
- June 1, 2012
- Center classification date
- September 21, 2012
- Code info
- Lot numbers 09101-121251 and 09101-121391
- More code info
- —