Home / Brands / Bracco Diagnostics
Bracco Diagnostics Recalls
7 recalls on record · September 5, 2012 to April 4, 2018 · Drugs
Recalls by year
12
13
14
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 4, 2018DrugsFDA
Bracco Diagnostics Inc. recalls E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM
Hazard: Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
February 19, 2014DrugsFDA
Bracco Diagnostics Inc recalls VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a s
Hazard: Failed Stability Testing: This product is below specification for preservative content.
August 28, 2013DrugsFDA
Bracco Diagnostics Inc recalls Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by
Hazard: Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
August 21, 2013DrugsFDA
Bracco Diagnostics Inc recalls Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle,
Hazard: Presence of foreign substance: One lot of the product may contain black foreign particles
October 3, 2012DrugsFDA
Bracco Diagnostics Inc recalls CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride
Hazard: GMP deviation; Sr-82 levels exceeded alert limit specification
September 5, 2012DrugsFDA
Bracco Diagnostics Inc recalls Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For
Hazard: Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
September 5, 2012DrugsFDA
Bracco Diagnostics Inc recalls Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Dia
Hazard: Short Fill: The product is being recalled due to a potential underfill of the affected vials.