D-0855-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 25, 2016
- Initiation Date
- March 23, 2016
- Termination Date
- November 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
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 Pattern
Nationwide
Code Information
All lots