Trigen Laboratories

FDA Regulatory Profile

Trigen Laboratories appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0579-2024, Class II) was initiated on June 17, 2024. Its most recent 510(k) clearance was granted on July 25, 2012.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0579-2024Class IIMethylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, ManufJune 17, 2024
D-1544-2014Class IIITriveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., April 17, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K121134TL TRISEB CREAMJuly 25, 2012
K110762AVO BARRIER TOPICAL EMULSIONNovember 18, 2011
K110757TL-CERMIDE SKIN BARRIER EMULSIONAugust 19, 2011