# FDA recall D-0271-2023

> **HTO Nevada, Inc.** · Class II · drug recall initiated 2023-02-09.

## Product

Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).

## Reason for recall

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

## Distribution

Nationwide in the USA and Canada.

## Key facts

- **Recall number:** D-0271-2023
- **Recalling firm:** HTO Nevada, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-09
- **Report date:** 2023-02-22
- **Termination date:** 2023-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Oswego, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0271-2023

## Citation

> AI Analytics. FDA recall D-0271-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0271-2023. Source: US FDA. Licensed CC0.

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