Recalls / Class I
Class ID-0244-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot # W06I28, exp 09/28/2024
Why it was recalled
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recalling firm
- Firm
- GFA Production Xiamen Co. Ltd.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- Huli Industrial Park No. 20, Meixi Road; Tong'An, Xiamen, N/A N/A, China
Distribution
- Quantity
- 2880 packets
- Distribution pattern
- Nationwide and Canada.
Timeline
- Recall initiated
- 2022-12-23
- FDA classified
- 2023-01-27
- Posted by FDA
- 2023-02-08
- Terminated
- 2025-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0244-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.