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
Reported: May 25, 2016 Initiated: March 23, 2016 #D-0855-2016
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.
Details
- Recalling Firm
- TMIG Inc
- Units Affected
- unknown
- Distribution
- Nationwide
- Location
- Marietta, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by TMIG Inc. Units affected: unknown.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2016. Severity: Moderate. Recall number: D-0855-2016.
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