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Trigen Laboratories

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
6
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