FDA recall D-0858-2018

Product

X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.

Reason for recall

CGMP Deviations: products may be contaminated with bacteria.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-05-25

Report date

2018-06-20

Termination date

2019-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0858-2018