Bracco Diagnostic Inc

FDA Drug Class III Terminated

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01

May 27, 2015 Bracco Diagnostic Inc 1008 boxes units

FDA Drug Class III Terminated

E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 0

September 18, 2014 Bracco Diagnostic Inc 58,050 packets units

FDA Drug Class III Terminated

E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

July 2, 2014 Bracco Diagnostic Inc 216,792 bottles units

FDA Drug Class I Terminated

Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco

November 21, 2012 Bracco Diagnostic Inc 5483 syringes (548.3 boxes) units

FDA Drug Class I Terminated

Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC

November 21, 2012 Bracco Diagnostic Inc 5736 syringes (573.6 boxes) units

FDA Drug Class III Terminated

Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc.

August 14, 2012 Bracco Diagnostic Inc 196,280 Vials units