Drug recall
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS…
FDA recall event 76272 · Class III · Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Key facts
| Event ID | 76272 |
|---|---|
| Recall numbers | D-0438-2017 |
| Recalling firm | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals |
| Product type | Drugs |
| Products | DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/ Degradation Specifications |
| Initiation date | Jan 16, 2017 |
| Report date | Feb 1, 2017 |
| Termination date | Sep 17, 2017 |
| City | Huntsville |
| State | AL |
| Country | United States |
| FEI number | 1039144 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: