FDA Drug recall D-1517-2019
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg ch…
- FDA Drug
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg ch… by Tris Pharma, citing superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specif….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1517-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-11 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tris Pharma |
| Distribution | US |
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
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.
Identifiers
| ndc | 27808-086-02 |
|---|---|
| ndc | 27808-086-01 |
| ndc | 27808-086-03 |
| code_info | Lot#: 14079, Exp 10/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1517-2019%22
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