FDA recall D-0244-2023

GFA Production Xiamen Co. Ltd. · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide and Canada.

Key facts

Status
Terminated
Initiation date
2022-12-23
Report date
2023-02-08
Termination date
2025-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Xiamen, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0244-2023