Bracco Diagnostics recalls
FDA enforcement reports naming Bracco Diagnostics Inc as the recalling firm.
- Recall reports
- 7
- Class I (serious)
- 0
- Most recent report
- Apr 4, 2018
- Apr 4, 2018E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured…Drug · Bracco Diagnostics Inc.Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.Class II
- Feb 19, 2014VoLumen Barium Sulfate Suspension (0Drug · Bracco Diagnostics IncFailed Stability Testing: This product is below specification for preservative content.Class III
- Aug 28, 2013Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-…Drug · Bracco Diagnostics IncFailed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.Class III
- Aug 21, 2013Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organica…Drug · Bracco Diagnostics IncPresence of foreign substance: One lot of the product may contain black foreign particlesClass II
- Oct 3, 2012CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of steril…Drug · Bracco Diagnostics IncGMP deviation; Sr-82 levels exceeded alert limit specificationClass II
- Sep 5, 2012Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Packa…Drug · Bracco Diagnostics IncLack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.Class II
- Sep 5, 2012Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx o…Drug · Bracco Diagnostics IncShort Fill: The product is being recalled due to a potential underfill of the affected vials.Class III