Renovo Patch — Class II drug recall D-0855-2016
Terminated recall by TMIG Inc, reported 2016-05-25, distributed nationwide. Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be
| Recall number | D-0855-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TMIG Inc, Marietta, GA, United States |
| Recall initiated | 2016-03-23 |
| Classified | 2016-05-17 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-11-15 |
| Distributed | Nationwide (US) |
| Reason classes | potency, unapproved product |
| NDC | 69176-0025-03 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0855-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.