FDAFDA · Food and drugs·Recall number D-1684-2012
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
Published October 3, 2012 · Recall initiated: June 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GMP deviation; Sr-82 levels exceeded alert limit specification
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARDIOGEN-82
- Manufacturer
- Bracco Diagnostics Inc
- Distributor
- Nationwide and United Kingdom
- Lot
- Lot numbers 09101-121251 and 09101-121391
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States