FDA recall D-1098-2023

Ecometics, Inc. · Class II · drug

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.

Reason for recall

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Distribution

Nationwide in the USA

Key facts

Status
Completed
Initiation date
2023-08-09
Report date
2023-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1098-2023