GFA Production (Xiamen) Co., Ltd. Recalls Asy Care First Aid® Burn Cream and First Aid Kits Because of Microbial Contamination

GFA Production (Xiamen) Co., Ltd issues a nationwide voluntary recall of Asy Care First Aid Burn Cream and First Aid Kits due to microbial contamination. The consumer-level recall was initiated after FDA testing revealed the presence of Bacillus licheniformis and Bacillus sonorensis in the products.

Consumers can identify these products with their 0.9 g single-use packets sold in boxes of 10 packets or with the First Aid Kits sold in a plastic box containing 40 packets. The products are being recalled from distributors and retailers nationwide.

Risk Statement

Using the contaminated Asy Care First Aid Burn Cream and First Aid Kits on immuno-compromised patients poses a serious risk of infection. It could also cause life-threatening adverse events such as sepsis, bacteremia, meningitis, and other invasive infections.

Non-immunocompromised patients may experience symptoms such as skin irritation, redness, swelling, and inflammation if the product is used. It is important to note that healthy individuals are not at a higher risk of these side effects but might still experience them.

The Easy Care first aid® AfterBurn® Cream 0.9 g packets and the First Aid Kits are used to treat minor burns. The products are manufactured by GFA Production (Xiamen) Co., Ltd.

Consumers can identify the single-use packets with the product name “Easy Care first aid® AfterBurn® Cream 0.9 g” and a lot number of W06I28 printed on the backside of each packet. The First Aid Kits can be identified with the same lot number printed on the box.

The products were distributed to retailers nationwide between March 4, 2022, and December 12, 2022. The table below contains all the information about the recalled products:

GFA Production (Xiamen) Co., Ltd is notifying its distributors and customers by email and is arranging for the return of all recalled products.

Retailers who still have the inventory of Easy Care first aid® AfterBurn® Cream, .9g single-use packets, and certain First Aid kits should stop selling them and return them to their distributors as soon as possible.

Consumers who have purchased these products should not use them and discard them safely.

GFA Production (Xiamen) Co., Ltd recommends that consumers speak with their healthcare provider if they have experienced any problems that may be related to using these products.

GFA Production (Xiamen) Co., Ltd is committed to the safety of its customers and apologizes for any inconvenience caused by this recall.

Consumers with questions can contact the U.S. distributor, Adventure Ready Brands, through telephone at 603-837-0285 on Monday to Friday from 9:00 AM and 5:00 PM Eastern Time or send an email to [email protected].

Any adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Please visit www.fda.gov/safety/medwatch/howtoreport for reporting instructions and additional information.