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GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid Burn Cream and First Aid Kits Due to Microbial Contamination

Company Announcement Date: December 23, 2022
FDA Publish Date: December 27, 2022
Product Type: Drugs
Reason for Announcement: Product is contaminated with Bacillus licheniformis and Bacillus sonorensis.
Company Name: GFA Production
Brand Name: Multiple brand names
Product Description: After Burn Cream and First Aid Kits containing After Burn Cream

Company Announcement - 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 0.9g 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. 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.  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
Product Number
Product Description
Lot number
Expiration

Box of 10 9999-1515 EasyCare First Aid AfterBurn Cream, 0.9g single-use packet W06I28  09/28/2024

First Aid Kit 1015-0150

Adventure Marine 150 W06I20 09/20/2024
0120-0213

Adventure First Aid 1.0 W06C05 W06F10 W06H15 03/05/2024
06/10/2024     08/15/2024

0120-0212 Adventure First Aid 1.5 W06H15 08/15/2024
9999-2129
 
Easy Care First Aid 25 Person 2009 ANSI
W05L28
12/28/2023
9999-2128
 
Easy Care First Aid 10 Person 2009 ANSI
 
W05L28 W06F10
W06H15
12/28/2023
06/10/2024
08/15/2021
 
9999-2150 Easy Care First Aid Class A ANSI 25 Person W06C05
W06H15 03/05/2024
08/15/2024
9999-2132 Easy Care First Aid? 25 Person 2009 ANSI W06H15 08/15/2024
2980-0700 CVS? First Aid Home W06H15 08/15/2024
9999-2132 Easy Care First Aid? 25 Person 2009 ANSI W06H15 08/15/2024
9999-2131 Easy Care First Aid? 10 Person 2009 ANSI W06H15 08/15/2024

GFA Production (Xiamen) Co., Ltd. is notifying its distributor by e-mail and is arranging for the return of all recalled Easy Care first aid? AfterBurn? Cream, .9g single-use packets and the certain First Aid kits that contain them.  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.

Consumers with questions regarding this recall can contact the U.S. distributor, Adventure Ready Brands, by email to regulatory@adventurereadybrands.com or telephone to 603-837-0285 on Monday to Friday from 9:00AM and 5:00PM, Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
?Complete and submit the report Online
?Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers: U.S. distributor, Adventure Ready Brands 603-837-0285 regulatory@adventurereadybrands.com
Media: Registrar Corp, US Agent for FDA communications 1-757-224-0177, ext. 414 sgurganus@registrarcorp.com