FDA Drug recall D-0438-2017
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
- FDA Drug
- Class III
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class III recall of DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56 by Vintage Pharmaceuticals, citing failed Impurities/ Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0438-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-01-16 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vintage Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/ Degradation Specifications
Identifiers
| code_info | Lot # 0000007104; Exp 05/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0438-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.