# FDA recall D-0441-2022

> **Edge Pharma, LLC** · Class II · drug recall initiated 2021-12-06.

## 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

## Reason for recall

CGMP Deviations

## Distribution

nationwide

## Key facts

- **Recall number:** D-0441-2022
- **Recalling firm:** Edge Pharma, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-06
- **Report date:** 2022-02-02
- **Termination date:** 2023-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colchester, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2022

## Citation

> AI Analytics. FDA recall D-0441-2022. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0441-2022. Source: US FDA. Licensed CC0.

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