Tris Pharma recalls
Tris Pharma appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2019-07-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2017-09-06 to 2019-07-31 |
| By agency | FDA Drug (8) |
| By classification | Class II (8) |
| By status | terminated (8) |
| Distribution named in notices | US |
Recalls
- Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg ch…
FDA Drug · Class II · 2019-07-31 · Tris Pharma
Reason: 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. - infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle,…
FDA Drug · Class II · 2019-02-20 · Tris Pharma
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. - Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ…
FDA Drug · Class II · 2019-02-20 · Tris Pharma
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. - Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (…
FDA Drug · Class II · 2019-02-20 · Tris Pharma
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. - Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ…
FDA Drug · Class II · 2018-12-26 · Tris Pharma
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen. - infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle…
FDA Drug · Class II · 2018-12-26 · Tris Pharma
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen. - Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ…
FDA Drug · Class II · 2018-12-26 · Tris Pharma
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen. - Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufac…
FDA Drug · Class II · 2017-09-06 · Tris Pharma
Reason: Defective container: Oral solution leaking from container.