Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Product description
ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
Lot numbers, UPCs & expiration codes
a) 0E280A, exp 10/23; 0E318A, exp 11/23; 1E109A, exp 3/24; 1E141A, exp 5/24; b) 0E280A, exp 11/23; 1E109A, 1E141A, exp 3/24
Where it was sold
Nationwide in the USA
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-1098-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Aug 9, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- a) 52,879 bottles; b) 12,054 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ecometics, Inc.
Original FDA data
Every field from FDA enforcement report D-1098-2023, exactly as published.
Show all FDA fields
- City
- Norwalk
- State
- CT
- Status
- Completed
- Country
- United States
- Event ID
- 92857
- Address
- 19 Concord St
- Code information
- a) 0E280A, exp 10/23; 0E318A, exp 11/23; 1E109A, exp 3/24; 1E141A, exp 5/24; b) 0E280A, exp 11/23; 1E109A, 1E141A, exp 3/24
- Postal code
- 06854-3706
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1098-2023
- Classification
- Class II
- Recalling firm
- Ecometics, Inc.
- Product quantity
- a) 52,879 bottles; b) 12,054 bottles
- Reason for recall
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2023