Drug product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
D-0439-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 353 jars
- Official record key
drug-enforcement:D-0439-2022
Official wording
Reason: CGMP Deviations
Code information: 07-2021-20@7 01-16-2022, 08-2021-11@6 02-07-2022, 08-2021-31@11 02-01-2022, 09-2021-14@11 02-01-2022, 09-2021-21@6 02-01-2022 & 10-2021-12@4 04-10-2022.
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations