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

FDA recall notice · announced May 25, 2016 · Tmig

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: All lots
Quantity: unknown
Status: Terminated
Products in this recall event:
- 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 (D-0855-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.