Drug product
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
D-0442-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 175 jars
- Official record key
drug-enforcement:D-0442-2022
Official wording
Reason: CGMP Deviations
Code information: 07-2021-13@7 01-09-2022 08/24/21 - 10/06/21 07-2021-27@8 01-23-2022 10/06/21 - 11/02/21 08-2021-10@5 02-01-2022 10/28/21 - 12/01/21
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations