BRACCO DIAGNOSTICS INC
BRACCO DIAGNOSTICS INC lists 31 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 0270-0091 | CardioGen-82 Injection, Solution | Rubidium Chloride Rb-82 150 mCi/1 | Rx |
| 0270-0083 | Choletec Injection, Powder, Lyophilized, For Solution | Mebrofenin 45 mg/1 | Rx |
| 0270-0149 | Cystografin Injection, Solution | Diatrizoate Meglumine 300 mg/mL | Rx |
| 0270-1410 | Cystografin Dilute Injection, Solution | Diatrizoate Meglumine 180 mg/mL | Rx |
| 0270-0445 | Gastrografin Liquid | Diatrizoate Meglumine 660 mg/mL; Diatrizoate Sodium 100 mg/mL | Rx |
| 0270-9400 | Iomeron Injection, Solution | Iomeprol 816 mg/mL | Rx |
| 0270-9350 | Iomeron Injection, Solution | Iomeprol 714 mg/mL | Rx |
| 0270-9300 | Iomeron Injection, Solution | Iomeprol 612 mg/mL | Rx |
| 0270-7400 | Iomeron Injection, Solution | Iomeprol 816 mg/mL | Rx |
| 0270-7350 | Iomeron Injection, Solution | Iomeprol 714 mg/mL | Rx |
| 0270-7300 | Iomeron Injection, Solution | Iomeprol 612 mg/mL | Rx |
| 0270-7250 | Iomeron Injection, Solution | Iomeprol 510 mg/mL | Rx |
| 0270-7017 | Iomervu Injection, Solution | Iomeprol 714 mg/mL | Rx |
| 0270-7018 | Iomervu Injection, Solution | Iomeprol 816 mg/mL | Rx |
| 0270-1314 | Isovue 200 Injection, Solution | Iopamidol 408 mg/mL | Rx |
| 0270-1317 | Isovue 250 Injection, Solution | Iopamidol 510 mg/mL | Rx |
| 0270-1315 | Isovue 300 Injection, Solution | Iopamidol 612 mg/mL | Rx |
| 0270-1316 | Isovue 370 Injection, Solution | Iopamidol 755 mg/mL | Rx |
| 0270-1412 | Isovue-m Injection, Solution | Iopamidol 612 mg/mL | Rx |
| 0270-1411 | Isovue-m Injection, Solution | Iopamidol 408 mg/mL | Rx |
| 0270-0556 | Kinevac Injection, Powder, Lyophilized, For Solution | Sincalide 5 ug/5mL | Rx |
| 0270-7097 | LumaSon Injection, Powder, Lyophilized, For Suspension | Sulfur Hexafluoride 60.7 mg/mg; Distearoylphosphatidylcholine, Dl- .19 mg/mg; Sodium… | Rx |
| 0270-7099 | LumaSon Kit | Rx | |
| 0270-5164 | MultiHance Injection, Solution | Gadobenate Dimeglumine 529 mg/mL | Rx |
| 0270-5264 | MultiHance Injection, Solution | Gadobenate Dimeglumine 529 mg/mL | Rx |
| 0270-1111 | ProHance Injection, Solution | Gadoteridol 279.3 mg/mL | Rx |
| 0270-7035 | Vueway Injection | Gadopiclenol 485.1 mg/mL | Rx |
| 0270-7030 | Vueway Injection | Gadopiclenol 485.1 mg/mL | Rx |
| 0270-7025 | Vueway Injection | Gadopiclenol 485.1 mg/mL | Rx |
| 0270-7020 | Vueway Injection | Gadopiclenol 485.1 mg/mL | Rx |
| 0270-7015 | Vueway Injection | Gadopiclenol 485.1 mg/mL | Rx |
Recalls by BRACCO DIAGNOSTICS INC
- D-1083-2014 Feb 19, 2014 · Class III
Failed Stability Testing: This product is below specification for preservative content. - D-914-2013 Aug 28, 2013 · Class III
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity. - D-885-2013 Aug 21, 2013 · Class II
Presence of foreign substance: One lot of the product may contain black foreign particles - D-1684-2012 Oct 3, 2012 · Class II
GMP deviation; Sr-82 levels exceeded alert limit specification - D-1665-2012 Sep 5, 2012 · Class II
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. - D-1663-2012 Sep 5, 2012 · Class III
Short Fill: The product is being recalled due to a potential underfill of the affected vials.