FDA Recall D-0244-2023
GFA Production Xiamen Co. Ltd. · Xiamen, N/A
Class I — life-threatening Terminated 949 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0244-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide and Canada.
- Recall initiated
- 2022-12-23
- Classified by FDA Center
- 2023-01-27
- FDA published
- 2023-02-08
- Terminated
- 2025-07-29
- Recalling firm
- GFA Production Xiamen Co. Ltd.
- Firm location
- Xiamen, N/A, China