ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207...
FDA Recall #D-1098-2023 — Class II — August 9, 2023
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.
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recalling Firm
Ecometics, Inc. — Norwalk, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 52,879 bottles; b) 12,054 bottles
Distribution
Nationwide in the USA
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
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated