Why it was recalled
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
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
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0855-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 23, 2016
- FDA report date
- May 25, 2016
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TMIG Inc
Original FDA data
Every field from FDA enforcement report D-0855-2016, exactly as published.
Show all FDA fields
- City
- Marietta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 73571
- Address
- 3535 Roswell Rd Ste 21
- Code information
- All lots
- Postal code
- 30062-6252
- Report date
- May 25, 2016
- Product type
- Drugs
- Recall number
- D-0855-2016
- Classification
- Class II
- Recalling firm
- TMIG Inc
- Product quantity
- unknown
- Termination date
- Nov 15, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 23, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 17, 2016