Drug product
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
D-0665-2016
Product summary
- Event
- Event 73174
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,308 boxes
- Official record key
drug-enforcement:D-0665-2016
Official wording
Reason: Marketed without an approved NDA/ANDA
Code information: Lot#: 20150326, Exp 03/2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA