Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, P
Summary
The FDA issued a Class I for Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care fir by GFA Production Xiamen Co. Ltd.. Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonor.
Details
Source
Drug Recall
External ID
D-0248-2023
Action Date
2023-02-08
Status
Terminated
Category
drug
Product Description
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
Lot/Code Info: Lot # W05L28, exp 12/28/2023
Quantity Affected: 37464 packets
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-23
Company
Xiamen, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 108 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
GFA Production Xiamen Co. Ltd. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GFA Production Xiamen Co. Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GFA Production Xiamen Co. Ltd. have FDA actions?
GFA Production Xiamen Co. Ltd. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0248-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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