Radiographic Contrast Agent
Where is Diatrizoic Acid made?
4 companies sell it under their own name. Their labels name 7 factories in Spain, the United States, Canada, Italy and India.
Spain 2United States 2Canada 1Italy 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bracco Diagnostics Inc. Gastrografin, Cystografin Dilute, Cystografin100 mg per 1 mL / 660 mg per 1 mL, 180 mg per 1 mL, 300 mg per 1 mL · NDC 0270-0445, 0270-1410, 0270-0149 | E-Z-EM Canada IncMakes it and tests it | Anjou, Canada | Problems found, fixed voluntarilyOct 2023 |
| Justesa Imagen, S.A.U.Makes the active ingredient, tests it, packages it and labels it | Coslada, Spain | Problems found, fixed voluntarilyMar 2022 | |
| Merck SLMakes the active ingredient, tests it, packages it and labels it | Mollet del Valles, Spain | Problems found, fixed voluntarilyMar 2025 | |
| Patheon Italia S.p.AMakes it and tests it | Ferentino, Italy | Problems found, fixed voluntarilyFeb 2022 | |
| Liebel-Flarsheim Company LLC100 mg per 1 mL / 600 mg per 1 mL · NDC 0019-4816 | Justesa Imagen, S.A.U.Makes the active ingredient | Coslada, Spain | Problems found, fixed voluntarilyMar 2022 |
| Liebel-Flarsheim Company LLCMakes it and tests it | Raleigh, NC, United States | Serious problems, FDA actionApr 2025 | |
| Camber Pharmaceuticals Inc.100 mg per 1 mL / 660 mg per 1 mL · NDC 31722-019 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Guardian Drug Company100 mg per 1 mL / 660 mg per 1 mL · NDC 53041-690, 53041-688 | Guardian Drug Company, Inc.Makes it | Dayton, NJ, United States | No problems foundJan 2026 |
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - May 15, 2015 · Class II · Mallinckrodt, Inc.
Labeling: incorrect or missing lot number and/or expiration date - Jun 21, 2013 · Class II · Bracco Diagnostics Inc
Presence of foreign substance: One lot of the product may contain black foreign particles
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.