Prescription drug
Where is Technetium Tc-99m Sulfur Colloid made?
2 companies sell it under their own name. Their labels name 2 factories in the United States.
United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Jubilant DraxImage Inc., dba Jubilant Radiopharma18.1 mg per 10 mL · NDC 65174-179 | Jubilant HollisterStier LLCMakes it, tests it, packages it and labels it | Spokane, WA, United States | No problems foundMar 2021 |
| Sun Pharmaceutical Industries, Inc. Kit for the Prepartion of Technetium Tc99m Sulfur Colloid10 mCi per 10 mL · NDC 45567-0030 | Sun Pharmaceutical Industries, Inc.Makes it, tests it, packages it and labels it | Billerica, MA, United States | Problems found, fixed voluntarilyApr 2025 |
Recalls
- Nov 22, 2024 · Class II · Jubilant Draximage Inc., dba Jubilant Radiopharma
Failed Stability Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.