Status
Completed
Drug Enforcement D-1098-2023
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Classification
Class II
Report Date
August 30, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- a) 52,879 bottles; b) 12,054 bottles
- Reason for recall
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Ecometics, Inc.
- Address
-
19 Concord St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1098-2023
- Event ID
- 92857
- Recall initiation date
- August 9, 2023
- Center classification date
- August 24, 2023
- Code info
- 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
- More code info
- —