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Safety Report: After Burn® Cream and First Aid Kits containing After Burn Cream - recalled due to bacteria, USA

1 year ago •source fda.gov

Recall notice

After Burn® Cream and First Aid Kits containing After Burn Cream - recalled due to bacteria photo #1

United States

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. The product was distributed nationwide to retailers from March 4, 2022 through December 12, 2022. To date, GFA Production (Xiamen) Co., Ltd. has not received any reports of adverse events related to this recall.

Risk Statement: In immunocompromised patients, the topical use of the contaminated Easy Care® AfterBurn® Cream 0.9g 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.

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.

Refer to the images below for guidance on where to find the lot code details.  If your product does not have a lot code that is listed in the below table then it is not part of this recall and can be used as intended.

Package: Box of 10
Product Number: 9999-1515
Product Description: EasyCare First Aid® AfterBurn® Cream, 0.9g single-use packet
Lot number: W06I28
Expiration: 09/28/2024

Package: First Aid Kit
Product Number: 1015-0150
Product Description: Adventure® Marine 150
Lot number: W06I20
Expiration: 09/20/2024

Package: First Aid Kit
Product Number: 0120-0213
Product Description: Adventure® First Aid 1.0
Lot number: W06C05 W06F10 W06H15
Expiration: 03/05/2024 06/10/2024 08/15/2024

Package: First Aid Kit
Product Number: 0120-0212
Product Description: Adventure® First Aid 1.5
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 9999-2129
Product Description: Easy Care First Aid® 25 Person 2009 ANSI
Lot number: W05L28
Expiration: 12/28/2023

Package: First Aid Kit
Product Number: 9999-2128
Product Description: Easy Care First Aid® 10 Person 2009 ANSI
Lot number: W05L28 W06F10 W06H15
Expiration: 12/28/2023 06/10/2024 08/15/2021

Package: First Aid Kit
Product Number: 9999-2150
Product Description: Easy Care First Aid® Class A ANSI 25 Person
Lot number: W06C05 W06H15
Expiration: 03/05/2024 08/15/2024

Package: First Aid Kit
Product Number: 9999-2132
Product Description: Easy Care First Aid® 25 Person 2009 ANSI
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 2980-0700
Product Description: CVS® First Aid Home
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 9999-2131
Product Description: Easy Care First Aid® 10 Person 2009 ANSI
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 9999-2132
Product Description: Easy Care First Aid® 25 Person 2009 ANSI
Lot number: W06H15
Expiration: 08/15/2024

Retailers that have any 0.9 g single-use packets or the First Aid kit lots listed above should return them to their distributor. Consumers should stop using the Easy Care first aid® AfterBurn® Cream .9g single-use packet and discard it.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: GFA Production
Brand name: Multiple brand names
Product recalled: After Burn® Cream and First Aid Kits containing After Burn Cream
Reason of the recall: Product is contaminated with Bacillus licheniformis and Bacillus sonorensis.
FDA Recall date: December 27, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gfa-production-xiamen-co-ltd-issues-voluntary-nationwide-recall-easy-care-first-aidr-burn-cream-and

#medicaldevices #us #bacterial #cream #sourcream

322

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