Home / Recalls / Bracco Diagnostics Inc / D-1684-2012

D-1684-2012 Class II Terminated

Recalled by Bracco Diagnostics Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
October 3, 2012
Initiation Date
June 1, 2012
Termination Date
March 18, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54 generators

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

Distribution Pattern

Nationwide and United Kingdom

Code Information

Lot numbers 09101-121251 and 09101-121391

Other recalls by Bracco Diagnostics Inc

  • D-0609-2018 Class II — E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manuf (March 8, 2018)
  • D-1083-2014 Class III — VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. (December 16, 2013)
  • D-914-2013 Class III — Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC (July 19, 2013)
  • D-885-2013 Class II — Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% O (June 21, 2013)
  • D-1663-2012 Class III — Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20m (April 16, 2012)
  • D-1665-2012 Class II — Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bul (April 16, 2012)