Drug 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
D-1149-2015
Product summary
- Event
- Event 71426
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 630 2 oz. Tubes, b) 859 5 oz. Jars
- Official record key
drug-enforcement:D-1149-2015
Official wording
Reason: Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Code information: Lot # 6086221, Exp 10/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent