June 2015 FDA Recall Drug by Indiana Botanic Gardens, Inc
D-1149-2015 - Superpotent Drug

This Class III drug recall was voluntarily initiated by Indiana Botanic Gardens, Inc on June 4, 2015 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1149-2015

Reason for Recall
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Initiated
06-04-2015
Reported
07-01-2015
Quantity
a) 630 2 oz. Tubes, b) 859 5 oz. Jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71426
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Indiana Botanic Gardens, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 6086221, Exp 10/16