FDA recall D-0438-2017
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals · Class III · drug
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
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-01-16
- Report date
- 2017-02-01
- Termination date
- 2017-09-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Huntsville, AL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0438-2017