Trigen Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0579-2024 | Class II | Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manuf | June 17, 2024 |
| D-1544-2014 | Class III | Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., | April 17, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121134 | TL TRISEB CREAM | July 25, 2012 |
| K110762 | AVO BARRIER TOPICAL EMULSION | November 18, 2011 |
| K110757 | TL-CERMIDE SKIN BARRIER EMULSION | August 19, 2011 |