Bracco Diagnostics Inc
Bracco Diagnostics Inc appears in FDA public data with 7 recalls, 2 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0609-2018, Class II) was initiated on March 8, 2018. Its most recent 510(k) clearance was granted on March 3, 2025.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 2
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0609-2018 | Class II | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Ca | March 8, 2018 |
| D-1083-2014 | Class III | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E- | December 16, 2013 |
| D-914-2013 | Class III | Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx On | July 19, 2013 |
| D-885-2013 | Class II | Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iod | June 21, 2013 |
| D-1684-2012 | Class II | CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogeni | June 1, 2012 |
| D-1665-2012 | Class II | Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for | April 16, 2012 |
| D-1663-2012 | Class III | Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufact | April 16, 2012 |