Promethazine Gel 50 mg/mL — Class II drug recall D-0419-2019
Terminated recall by Duren Health Mart Pharmacy, reported 2019-02-06, distributed in TN. Lack of Processing Controls.
| Recall number | D-0419-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Duren Health Mart Pharmacy, Waynesboro, TN, United States |
| Recall initiated | 2018-12-17 |
| Classified | 2019-01-28 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2022-01-19 |
| Distributed | TN |
| Quantity | 876 cc |
| NDC | 00002-1901-03 |
Product
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
Reason for recall
Lack of Processing Controls.
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-0419-2019. 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.