# FDA recall D-0665-2016

> **Bonita Pharmaceuticals, LLC** · Class II · drug recall initiated 2016-01-27.

## Product

Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI  48185-9120, USA NDC 53598-0012-15

## Reason for recall

Marketed without an approved NDA/ANDA

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0665-2016
- **Recalling firm:** Bonita Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-27
- **Report date:** 2016-02-24
- **Termination date:** 2019-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westland, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2016

## Citation

> AI Analytics. FDA recall D-0665-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0665-2016. Source: US FDA. Licensed CC0.

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