Radiographic Contrast Agent
Where is Iopamidol made?
2 companies sell it under their own name and 1 repackager rebottle it. Their labels name 6 factories in Italy, Germany, India and China.
Italy 3Germany 1India 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bracco Diagnostics Inc. Isovue200, Isovue-M, Isovue250, Isovue300, Isovue370408 mg per 1 mL, 510 mg per 1 mL, 612 mg per 1 mL, 755 mg per 1 mL · NDC 0270-1314, 0270-1411, 0270-1317 +3 | BIPSO GmbHMakes it and tests it | Singen (Hohentwiel), Germany | Problems found, fixed voluntarilyMay 2022 |
| Bracco Imaging SpaMakes the active ingredient | Ceriano Laghetto, Italy | Problems found, fixed voluntarilyOct 2022 | |
| Patheon Italia S.p.AMakes it and tests it | Ferentino, Italy | Problems found, fixed voluntarilyFeb 2022 | |
| S.m. Farmaceutici SRLMakes it and tests it | Tito, Italy | Problems found, fixed voluntarilyMar 2026 | |
| Slate Run Pharmaceuticals, LLC.408 mg per 1 mL, 510 mg per 1 mL, 612 mg per 1 mL, 755 mg per 1 mL · NDC 70436-124, 70436-211, 70436-125 +3 | Divi's Laboratories LimitedMakes the active ingredient | Yadadri Bhuvanagiri District, India | No problems foundNov 2025 |
| Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
Repackaged by
These companies buy Iopamidol in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- General Injectables & Vaccines, Inc.:
52584-411
Recalls
- Nov 21, 2012 · Class I · Bracco Diagnostic Inc · 2 recall notices
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.