# FDA recall D-0439-2022

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

## 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

## Reason for recall

CGMP Deviations

## Distribution

nationwide

## Key facts

- **Recall number:** D-0439-2022
- **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-0439-2022

## Citation

> AI Analytics. FDA recall D-0439-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0439-2022. Source: US FDA. Licensed CC0.

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