Prescription drug
Where is Dotatate Gallium Ga-68 made?
1 company sell it under their own name. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Advanced Accelerator Applications USA, Inc Netspot40 ug · NDC 69488-001 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Mar 18, 2022 · Class III · Advanced Accelerator Applications USA, Inc.
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. - Jan 10, 2020 · Class II · Advanced Accelerator Applications USA, Inc.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.