Bracco Diagnostic recalls
FDA enforcement reports naming Bracco Diagnostic Inc as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 2
- Most recent report
- Jul 1, 2015
- Jul 1, 2015E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx…Drug · Bracco Diagnostic IncFailed stability specifications:This recall has been initiated due to out of specification results for viscosity.Class III
- Oct 15, 2014E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0Drug · Bracco Diagnostic IncSubpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.Class III
- Aug 20, 2014E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured b…Drug · Bracco Diagnostic IncSubpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.Class III
- Feb 13, 2013Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 10…Drug · Bracco Diagnostic IncPresence of Particulate Matter; fibers identified as cellulose and polyvinylClass I
- Feb 13, 2013Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx…Drug · Bracco Diagnostic IncPresence of Particulate Matter; fibers identified as cellulose and polyvinylClass I
- Dec 26, 2012Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, N…Drug · Bracco Diagnostic IncPresence of Particulate Matter; potential for charcoal particulatesClass III