FDA Drug Recalls

Recalls / Class II

Class IID-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

Affected lot / code info
Lot. 172598G, Exp. 7/4/2019

Why it was recalled

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

Recalling firm

Firm
Product Quest Manufacturing LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
330 Carswell Ave, N/A, Daytona Beach, Florida 32117-4416

Distribution

Quantity
4,692 tubes
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2018-08-03
FDA classified
2018-10-16
Posted by FDA
2018-10-24
Terminated
2021-03-30
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0068-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.