Drug product
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
D-0441-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 418 jars
- Official record key
drug-enforcement:D-0441-2022
Official wording
Reason: CGMP Deviations
Code information: 06-2021-29@15 12-26-2021, 07-2021-12@7 01-08-2022, 08-2021-03@7 01-30-2022, 08-2021-25@5 02-01-2022, 09-2021-10@4 02-01-2022, 09-2021-22@6 03-01-2022 & 10-2021-06@11 04-04-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations