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
Reported: October 3, 2012 Initiated: June 1, 2012 #D-1684-2012
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
Reason for Recall
GMP deviation; Sr-82 levels exceeded alert limit specification
Details
- Recalling Firm
- Bracco Diagnostics Inc
- Units Affected
- 54 generators
- Distribution
- Nationwide and United Kingdom
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bracco Diagnostics Inc. Units affected: 54 generators.
Why was this product recalled? ▼
GMP deviation; Sr-82 levels exceeded alert limit specification
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2012. Severity: Moderate. Recall number: D-1684-2012.
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