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December 23, 2022December 23, 2022 – Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care First Aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the product to be contaminated with Bacillus licheniformis, and Bacillus sonorensis.
Risk Statement: In immunocompromised patients, the topical use of the contaminated Easy Care® AfterBurn® Cream 0.9 g single-use packets could potentially result in severe or life-threatening adverse events such as bacteremia, sepsis, and peritonitis. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance skin infections, but in this population the infections are expected to be less severe and more readily responsive to treatment. To date, GFA Production (Xiamen) Co., Ltd. has not received any reports of adverse events related to this recall.
The Easy Care First Aid® AfterBurn® Cream 0.9 g single-use packet is used as an over the counter first-aid treatment for minor burns. The single use packets bear lot number W06I28 and are packaged in boxes of ten or included in the certain first aid kits named below. The lot number of the single use packet can be found on the back of the packet. The lot number for the first aid kit that contains the single use packet can be found on each kit, either on the product hang tag or on the bottom of the kit. The product was distributed nationwide to retailers from March 4, 2022 through December 12, 2022. Refer to the images below for guidance on where to find the lot code details.