Recalls / Class I
Class ID-0250-2023
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 Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150
- Affected lot / code info
- Lot #: W06C05, exp 03/05/2024; 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
- 66400 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-0250-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.