Easy Care first aid Burn Cream recalled over sterility concerns

Recall date

December 23, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GFA Production Xiamen Co. Ltd. recalls Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets…

Recall number

D-0244-2023

FDA classification

Class I

Brand / firm

GFA Production Xiamen Co. Ltd.

Sold / distributed

Nationwide and Canada.

Why it was recalled

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9999-1515