Recalls / Class I
Class ID-0251-2023
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 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
- Affected lot / code info
- Lot # W06H15, exp 08/15/2024
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
- 8280 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-0251-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.