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
D-0433-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 cartons
- Official record key
drug-enforcement:D-0433-2022
Official wording
Reason: CGMP Deviations
Code information: 06-2021-23@6 12-20-2021, 09-2021-15@4 03-14-2022 & 10-2021-04@10 04-02-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations