Why it was recalled
Marketed without an approved NDA/ANDA
Product description
Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15
Lot numbers, UPCs & expiration codes
Lot#: 20150326, Exp 03/2018
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-0665-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 27, 2016
- FDA report date
- Feb 24, 2016
- Quantity
- 3,308 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bonita Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0665-2016, exactly as published.
Show all FDA fields
- City
- Westland
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 73174
- Address
- 6380 Commerce Drive
- Code information
- Lot#: 20150326, Exp 03/2018
- Postal code
- 48185-9120
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0665-2016
- Classification
- Class II
- Recalling firm
- Bonita Pharmaceuticals, LLC
- Product quantity
- 3,308 boxes
- Termination date
- Mar 6, 2019
- Reason for recall
- Marketed without an approved NDA/ANDA
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 12, 2016