June 2012 FDA Recall Cardiogen-82 by Bracco Diagnostics Inc
D-1684-2012 - GMP deviation; Sr-82 levels exceeded alert limit specification

This Class II drug recall was voluntarily initiated by Bracco Diagnostics Inc on June 1, 2012 for the product Cardiogen-82. The FDA reported the reason for recall as gmp deviation; sr-82 levels exceeded alert limit specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1684-2012

Reason for Recall
GMP deviation; Sr-82 levels exceeded alert limit specification
Initiated
06-01-2012
Reported
10-03-2012
Quantity
54 generators

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62866
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bracco Diagnostics Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and United Kingdom
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-18-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot numbers 09101-121251 and 09101-121391

Affected Packages Involved in this Recall

0270-0091-01 Cardiogen-82