FDA recall D-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

Reason for recall

GMP deviation; Sr-82 levels exceeded alert limit specification

Distribution

Nationwide and United Kingdom

Key facts

Status

Terminated

Initiation date

2012-06-01

Report date

2012-10-03

Termination date

2013-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1684-2012