Key Takeaway

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 Indian by Indiana Botanic Gardens, Inc was recalled on June 4, 2015. The hazard: Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.

FDA Drug Class III Terminated

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 Indian

Recalled: June 4, 2015 ~a) 630 2 oz. Tubes, b) 859 5 oz. Jars units affected D-1149-2015

Description

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

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 Indian

Drugs

Company Information

Indiana Botanic Gardens, Inc

Hobart, IN, United States

View all 2 recalls by Indiana Botanic Gardens, Inc →

Distribution

Nationwide and Puerto Rico

Related Recalls

Frequently Asked Questions

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