Why it was recalled
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Product 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
Lot numbers, UPCs & expiration codes
Lot # 6086221, Exp 10/16
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1149-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 4, 2015
- FDA report date
- Jul 1, 2015
- Quantity
- a) 630 2 oz. Tubes, b) 859 5 oz. Jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Indiana Botanic Gardens, Inc
Original FDA data
Every field from FDA enforcement report D-1149-2015, exactly as published.
Show all FDA fields
- City
- Hobart
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 71426
- Address
- 3401 W 37th Ave
- Code information
- Lot # 6086221, Exp 10/16
- Postal code
- 46342-1751
- Report date
- Jul 1, 2015
- Product type
- Drugs
- Recall number
- D-1149-2015
- Classification
- Class III
- Recalling firm
- Indiana Botanic Gardens, Inc
- Product quantity
- a) 630 2 oz. Tubes, b) 859 5 oz. Jars
- Termination date
- Mar 21, 2016
- Reason for recall
- Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 4, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2015