Drug 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
D-0855-2016
Product summary
- Firm
- TMIG Inc
- Event
- Event 73571
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-0855-2016
Official wording
Reason: Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
subpotent