# FDA recall D-1517-2019

> **Tris Pharma Inc.** · Class II · drug recall initiated 2019-07-11.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-1517-2019
- **Recalling firm:** Tris Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-11
- **Report date:** 2019-07-31
- **Termination date:** 2021-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monmouth Junction, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2019

## Citation

> AI Analytics. FDA recall D-1517-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1517-2019. Source: US FDA. Licensed CC0.

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