Tris Pharma Inc
NDC labeler code: 27808
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- PregabalinLyrica, Lyrica CR · 7 products
- LacosamideVimpat, Motpoly XR · 4 products
- PaliperidoneInvega · 4 products
- FebuxostatUloric · 2 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
- Cyproheptadine1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 17, 2022 | ANDA208308 | Lacosamide LACOSAMIDE | Regcon Holdings |
| January 26, 2022 | ANDA214076 | Potassium chloride POTASSIUM CHLORIDE | Tris Pharma Inc |
| December 21, 2021 | ANDA205431 | Cyproheptadine CYPROHEPTADINE HYDROCHLORIDE | Tris Pharma Inc |
| July 15, 2021 | ANDA214322 | Pregabalin PREGABALIN | Tris Pharma Inc |
| October 29, 2020 | ANDA212807 | Paliperidone PALIPERIDONE | Cspc Ouyi |
| December 30, 2019 | ANDA210292 | Febuxostat FEBUXOSTAT | Regcon Holdings |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2019
-
July 11, 2019 · Class II · Terminated · D-1517-2019 · Hydrocodone polistirex and chlorpheniramine polistirex
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.
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactur
2017
-
June 15, 2017 · Class II · Terminated · D-1126-2017 · Morphine sulfate
Defective container: Oral solution leaking from container.
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, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
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Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026