FDA recall D-0068-2019

Product

Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341

Reason for recall

Superpotent Drug: high out of specification assay results for the menthol ingredient.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-08-03

Report date

2018-10-24

Termination date

2021-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Daytona Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0068-2019