Drug product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
D-0443-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1861 jars
- Official record key
drug-enforcement:D-0443-2022
Official wording
Reason: CGMP Deviations
Code information: 07-2021-12@9 01-08-2022 07/22/21 - 08/11/21 08-2021-11@10 02-07-2022 08/25/21 - 09/10/21 08-2021-12@12 02-08-2022 09/07/21 - 10/06/21 09-2021-22@5 03-21-2022 10/12/21 - 10/28/21 10-2021-07@8 04-05-2022 10/25/21 - 10/28/21 10-2021-08@4 04-06-2022 10/28/21 - 11/12/21 11-2021-01@7 04-30-2022 11/15/21 - 12/01/21
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations