Hydrocodone Polistirex and Chlorpheniramine Polistirex… — Class II drug recall D-1517-2019
Terminated recall by Tris Pharma Inc., reported 2019-07-31, distributed nationwide. Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredi
| Recall number | D-1517-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tris Pharma Inc., Monmouth Junction, NJ, United States |
| Recall initiated | 2019-07-11 |
| Classified | 2019-07-24 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,550 bottles |
| Reason classes | potency, specification failure |
| NDC | 27808-0086, 27808-0086-01, 27808-0086-02, 27808-0086-03 |
| Lot numbers | 14079 |
| Expiration dates | 2021-10 |
Product
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, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1517-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.