FDA recall D-0855-2016

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

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

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