FDA-Drug2016-05-25Class II

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

TMIG Inc
Hazard

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

Sold states
Nationwide
Affected count
unknown
Manufactured in
3535 Roswell Rd Ste 21, N/A, Marietta, GA, United States
Products
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

Official notice

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

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