Drug product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
D-0434-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63 vials
- Official record key
drug-enforcement:D-0434-2022
Official wording
Reason: CGMP Deviations
Code information: 09-2021-15@5 12-14-2021 & 10-2021-01@4 12-30-2021
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations