Prescription drug
Where is Human Serum Albumin I-131 made?
1 company sell it under their own name. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Iso-Tex Diagnostics, Inc. Volumex, Megatope0.025 mCi per 1 mL, 1 mCi per 1 mL · NDC 50914-7720, 50914-7731 | Iso-Tex Diagnostics, Inc.Makes it | Alvin, TX, United States | Serious problems, FDA actionFeb 2026 |
Recalls
- Apr 15, 2019 · Class II · Iso-Tex Diagnostics, Inc
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured. - Mar 11, 2019 · Class II · Iso-Tex Diagnostics, Inc
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.