D-0665-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- January 27, 2016
- Termination Date
- March 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,308 boxes
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
Reason for Recall
Marketed without an approved NDA/ANDA
Distribution Pattern
Nationwide
Code Information
Lot#: 20150326, Exp 03/2018