FDA recall D-1149-2015

Product

Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342

Reason for recall

Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-06-04

Report date

2015-07-01

Termination date

2016-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hobart, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2015