Gadolinium-based Contrast Agent
Where is Gadolinium Cation (3+) made?
8 companies sell it under their own name. Their labels name 22 factories in China, Germany, Italy, Norway, France, South Korea and 3 others.
China 8Germany 4Italy 2Norway 2France 2South Korea 1India 1United States 1Finland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| GE Healthcare Inc.376.9 mg per 1 mL, 604.72 mg per 1 mL · NDC 0407-2943, 0407-1066 | GE Healthcare (Shanghai) Co Ltd.Makes it, tests it, packages it and labels it | China (Shanghai) Pilot Free Trade Zone, China | Problems found, fixed voluntarilyOct 2025 |
| GE Healthcare ASMakes it, tests it, packages it and labels it | Oslo, Norway | Problems found, fixed voluntarilyApr 2024 | |
| GE Healthcare AS avd LindesnesMakes the active ingredient and tests it | Lindesnes, Norway | Problems found, fixed voluntarilyFeb 2025 | |
| ST Pharm Co., Ltd.Makes the active ingredient and tests it | Ansan, South Korea | Problems found, fixed voluntarilyJul 2023 | |
| Vanamali Organics Private LimitedMakes the active ingredient and tests it | Hyderabad, India | Not inspected on record | |
| Guerbet LLC Dotarem376.9 mg per 1 mL · NDC 67684-2000, 67684-2001, 67684-3001 | Astrea MontsMakes it, tests it, packages it and labels it | Monts, France | Serious problems, FDA actionOct 2022 |
| Liebel-Flarsheim Company LLCMakes it, packages it and labels it | Raleigh, NC, United States | Serious problems, FDA actionApr 2025 | |
| PCAS Finland OyMakes the active ingredient and tests it | Turku, Finland | Problems found, fixed voluntarilyJan 2024 | |
| SimafexMakes the active ingredient | Marans, France | Problems found, fixed voluntarilyJan 2025 | |
| Bayer HealthCare Pharmaceuticals Inc. Eovist, Gadavist181.43 mg per 1 mL, 604.72 mg per 1 mL · NDC 50419-320, 50419-325 | Bayer AGMakes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Berlin, Germany | Problems found, fixed voluntarilyJun 2024 |
| Bayer AGMakes the active ingredient and tests it | Bergkamen, Germany | Problems found, fixed voluntarilyNov 2024 | |
| Dynamit Nobel GmbH Explosivstoff- und SystemtechnikMakes the active ingredient | Leverkusen, Germany | Problems found, fixed voluntarilySep 2023 | |
| Bracco Diagnostics Inc. MultiHance529 mg per 1 mL · NDC 0270-5164, 0270-5264 | 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 | |
| Fresenius Kabi USA, LLC376.9 mg per 1 mL, 604.72 mg per 1 mL · NDC 65219-080, 65219-082, 65219-084 +5 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)Makes it | Lianyungang, China | Problems found, fixed voluntarilyAug 2023 |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)Makes it | Lianyungang, China | Serious problems, FDA actionJan 2024 | |
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)Makes the active ingredient | Lianyungang, China | Problems found, fixed voluntarilyApr 2026 | |
| Slate Run Pharmaceuticals, LLC.376.9 mg per 1 mL, 604.72 mg per 1 mL · NDC 70436-123, 70436-216, 70436-217 +4 | Anhui Poly Pharm. Co., Ltd.Makes the active ingredient | Anqing, China | Problems found, fixed voluntarilyFeb 2025 |
| Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 | |
| Viwit Pharmaceutical Co., Ltd.604.72 mg per 1 mL · NDC 42337-007, 42337-005, 42337-006 | Viwit Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Zaozhuang, China | Not inspected on record |
| Viwit Pharmaceutical Co., Ltd.Makes the active ingredient and tests it | Tengzhou, China | No problems foundJul 2024 | |
| Zydus Pharmaceuticals (USA) Inc.604.72 mg per 1 mL · NDC 70710-2064, 70710-2065, 70710-2066 | Viwit Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Zaozhuang, China | Not inspected on record |
Recalls
- Apr 16, 2012 · Class II · Bracco Diagnostics Inc
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. - Apr 16, 2012 · Class III · Bracco Diagnostics Inc
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.