DEXAMETHASONE ELIXIR — Class III drug recall D-0438-2017
Terminated recall by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, reported 2017-02-01, distributed nationwide. Failed Impurities/ Degradation Specifications
| Recall number | D-0438-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2017-01-16 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,568 bottles |
| Reason classes | specification failure |
| NDC | 00603-1147-56 |
| Lot numbers | 0000007104, 05/17 |
Product
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Reason for recall
Failed Impurities/ Degradation Specifications
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-0438-2017. 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.