Bonita Pharmaceuticals, LLC recalls Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged…

Recall date

January 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0665-2016

FDA classification

Class II

Brand / firm

Bonita Pharmaceuticals, LLC

Sold / distributed

Nationwide

Why it was recalled

Marketed without an approved NDA/ANDA

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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