Tris Pharma Inc.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
16
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1517-2019Class IIHydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 1July 11, 2019
D-0493-2019Class IIInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye FreJanuary 15, 2019
D-0494-2019Class IIinfants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-FreeJanuary 15, 2019
D-0495-2019Class IIInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye FreJanuary 15, 2019
D-0336-2019Class IIInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-FreNovember 26, 2018
D-0337-2019Class IIInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye FreNovember 26, 2018
D-0335-2019Class IIinfants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-FreeNovember 26, 2018
D-1126-2017Class IIMorphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mLJune 15, 2017