Recalls / Class II
Class IID-1098-2023
Product
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.
- Affected lot / 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
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, N/A, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- a) 52,879 bottles; b) 12,054 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-09
- FDA classified
- 2023-08-24
- Posted by FDA
- 2023-08-30
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1098-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.