Tris Pharma Inc.
Tris Pharma Inc. appears in FDA public data with 8 recalls, 0 510(k) clearances, 16 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1517-2019, Class II) was initiated on July 11, 2019.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 16
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1517-2019 | Class II | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 1 | July 11, 2019 |
| D-0494-2019 | Class II | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free | January 15, 2019 |
| D-0493-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Fre | January 15, 2019 |
| D-0495-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Fre | January 15, 2019 |
| D-0335-2019 | Class II | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free | November 26, 2018 |
| D-0337-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Fre | November 26, 2018 |
| D-0336-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Fre | November 26, 2018 |
| D-1126-2017 | Class II | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL | June 15, 2017 |