Prescription drug
Where is Mebrofenin made?
3 companies sell it under their own name. Their labels name 4 factories in the United States and Switzerland.
United States 3Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bracco Diagnostics Inc. Choletec45 mg · NDC 0270-0083 | Jubilant HollisterStier LLCMakes it and tests it | Spokane, WA, United States | No problems foundMar 2021 |
| Sigma-Aldrich Production GmbHMakes the active ingredient | Buchs, Switzerland | No problems foundSep 2023 | |
| AnazaoHealth Corporation10 mg · NDC 51808-216 | AnazaoHealth CorporationMakes it | Las Vegas, Nevada, United States | Serious problems, FDA actionAug 2025 |
| Sun Pharmaceutical Industries, Inc.45 mg per 10 mL · NDC 45567-0455 | Sun Pharmaceutical Industries, Inc.Makes it | Billerica, MA, United States | Problems found, fixed voluntarilyApr 2025 |
Recalls
- Apr 10, 2018 · Class II · Pharmalucence, Inc.
Failed Stability Specifications - Aug 14, 2012 · Class III · Bracco Diagnostic Inc
Presence of Particulate Matter; potential for charcoal particulates
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.