Collagen-specific Enzyme
Where is Collagenase Clostridium Histolyticum 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 |
|---|---|---|---|
| Smith & Nephew, Inc Collagenase Santyl250 [arb'U] per 1 g · NDC 50484-010 | Halo Pharmaceutical IncMakes it and packages it | Whippany, NJ, United States | No problems foundDec 2025 |
| LTS Lakewood, LLCMakes it, tests it and packages it | Lakewood, NJ, United States | Problems found, fixed voluntarilyJul 2026 | |
| ENDO USA, Inc. Xiaflex0.9 mg · NDC 66887-003 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.