FDA recall D-0665-2016

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

Reason for recall

Marketed without an approved NDA/ANDA

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-01-27

Report date

2016-02-24

Termination date

2019-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westland, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2016