Drug product
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03
D-0435-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 vials
- Official record key
drug-enforcement:D-0435-2022
Official wording
Reason: CGMP Deviations
Code information: 08-2021-03@8 12-31-2021 & 09-2021-07@10 02-04-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations