FDA recall D-0835-2018

Product

screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.

Reason for recall

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

Distribution

Nationwide in the U.S.A.

Key facts

Status

Terminated

Initiation date

2018-05-16

Report date

2018-05-30

Termination date

2018-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mc Kees Rocks, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0835-2018