Tris Pharma recalls
FDA enforcement reports naming Tris Pharma Inc. as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Jul 31, 2019
- Jul 31, 2019Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (eq…Drug · Tris Pharma Inc.Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.Class II
- Feb 20, 2019Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1Drug · Tris Pharma Inc.Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.Class II
- Feb 20, 2019infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1Drug · Tris Pharma Inc.Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.Class II
- Feb 20, 2019Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1Drug · Tris Pharma Inc.Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.Class II
- Dec 26, 2018infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1Drug · Tris Pharma Inc.Superpotent Drug: recalled lots may have higher concentration of ibuprofen.Class II
- Dec 26, 2018Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1Drug · Tris Pharma Inc.Superpotent Drug: recalled lots may have higher concentration of ibuprofen.Class II
- Dec 26, 2018Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1Drug · Tris Pharma Inc.Superpotent Drug: recalled lots may have higher concentration of ibuprofen.Class II
- Sep 6, 2017Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 ozDrug · Tris Pharma Inc.Defective container: Oral solution leaking from container.Class II