Drug product
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
D-0429-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1173 vials
- Official record key
drug-enforcement:D-0429-2022
Official wording
Reason: CGMP Deviations
Code information: 06-2021-11@6 12-08-2021, 07-2021-08@13 01-04-2022, 08-2021-06@6 02-02-2022, 08-2021-20@10 02-16-2022, 08-2021-26@6 02-22-2022, 08-2021-27@7 02-23-2022, 09-2021-02@5 03-01-2022, 09-2021-17@8 03-16-2022 & 09-2021-29@12 03-28-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations