# FDA recall D-0855-2016

> **TMIG Inc** · Class II · drug recall initiated 2016-03-23.

## Product

Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03

## Reason for recall

Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0855-2016
- **Recalling firm:** TMIG Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-23
- **Report date:** 2016-05-25
- **Termination date:** 2017-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2016

## Citation

> AI Analytics. FDA recall D-0855-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0855-2016. Source: US FDA. Licensed CC0.

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