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Bracco Diagnostic Recalls
6 recalls on record · December 26, 2012 to July 1, 2015 · Drugs
Recalls by year
12
13
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 1, 2015DrugsFDA
Bracco Diagnostic Inc recalls E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Cana
Hazard: Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
October 15, 2014DrugsFDA
Bracco Diagnostic Inc recalls E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for
Hazard: Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
August 20, 2014DrugsFDA
Bracco Diagnostic Inc recalls E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiar
Hazard: Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
February 13, 2013DrugsFDA
Bracco Diagnostic Inc recalls Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Di
Hazard: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
February 13, 2013DrugsFDA
Bracco Diagnostic Inc recalls 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
Hazard: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
December 26, 2012DrugsFDA
Bracco Diagnostic Inc recalls Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, Fo
Hazard: Presence of Particulate Matter; potential for charcoal particulates