Prescription drug
Where is Thrombin Alfa made?
2 companies sell it under their own name. Their labels name 3 factories in the United States and Italy.
United States 2Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| The Medicines Company Recothrom1000 [iU] per 1 mL · NDC 65293-006, 65293-007 | AbbVie Bioresearch CenterMakes it and tests it | Worcester, MA, United States | No problems foundSep 2025 |
| Catalent Indiana, LLCMakes it and tests it | Bloomington, IN, United States | Serious problems, FDA actionApr 2026 | |
| Patheon Italia S.p.AMakes it and tests it | Ferentino, Italy | Problems found, fixed voluntarilyFeb 2022 | |
| Baxter Healthcare Corporation Recothrom1000 [iU] per 1 mL · NDC 0338-0322, 0338-0326, 0338-0330 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.