FDA recall D-0433-2022
Edge Pharma, LLC · Class II · drug
Product
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
Reason for recall
CGMP Deviations
Distribution
nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2021-12-06
- Report date
- 2022-02-02
- Termination date
- 2023-06-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Colchester, VT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2022