FDA recall D-0253-2023

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

Product

Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131

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-0253-2023