Bracco Diagnostic recalls
Bracco Diagnostic appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2015-07-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2012-12-26 to 2015-07-01 |
| By agency | FDA Drug (6) |
| By classification | Class III (4), Class I (2) |
| By status | terminated (6) |
| Distribution named in notices | US |
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 Canada Inc. a subsidiar…
FDA Drug · Class III · 2015-07-01 · Bracco Diagnostic
Reason: Failed stability specifications:This recall has been initiated due to out of specification results for viscosity. - 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
FDA Drug · Class III · 2014-10-15 · Bracco Diagnostic
Reason: Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. - 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.,…
FDA Drug · Class III · 2014-08-20 · Bracco Diagnostic
Reason: Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months. - 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-…
FDA Drug · Class I · 2013-02-13 · Bracco Diagnostic
Reason: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl - Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Pri…
FDA Drug · Class I · 2013-02-13 · Bracco Diagnostic
Reason: Presence of Particulate Matter; fibers identified as cellulose and polyvinyl - Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use,…
FDA Drug · Class III · 2012-12-26 · Bracco Diagnostic
Reason: Presence of Particulate Matter; potential for charcoal particulates