Contaminated OTC Burn Cream Prompts Class I Recall

A Class I recall has been issued for Easy Care first aid AfterBurn Cream, and first aid kits containing Easy Care AfterBurn Cream, after US Food and Drug Administration (FDA) analysis of the product revealed microbial contamination. According to the February 8, 2023, FDA Enforcement Report, the results showed the first aid cream was contaminated with Bacillus lichenformis and Bacillus sonorensis. 

Class I is the FDA’s most serious classification, indicating that use of the affected product could cause serious adverse health consequences or death.

“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,” stated recalling firm GFA Production (Xiamen) Co Ltd, Xiamen, China, in a December 23, 2022, company announcement. “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 recall includes the following products, which were distributed to retailers in the United States and Canada:

• EasyCare First Aid AfterBurn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9-g single-use packets, 10 per box (product 9999-1515, NDC 90107-0210), made in China for Adventure Ready Brands, Littleton, New Hampshire, from lot W06I28 (Exp. 9/28/24);
• Adventure Marine 150 First-Aid Kit (product 1015-0150), from lot W06I20 (Exp. 9/20/24);
• Adventure First Aid 1.0 first aid kit (product 0120-0213), from lots W06C05 (Exp. 3/5/24), W06F10 (Exp. 6/10/24), and W06H15 (Exp. 8/15/24);
• Adventure First Aid 1.5 first aid kit (product 0120-0212), from lot W06H15 (Exp. 8/15/24);
• Easy Care First Aid 25 Person 2009 ANSI first aid kit (product 9999-2129), from lot W05L28 (Exp. 12/28/23);
• Easy Care First Aid 10 Person 2009 ANSI first aid kit (product 9999-2128), from lots W05L28 (Exp. 12/28/23), W06F10 (Exp. 6/10/24), and W06H15 (8/15/21);
• Easy Care First Aid Class A ANSI 25 Person first aid kit (product 9999-2150), from lots W06C05 (Exp. 3/5/24) and W06H15 (8/15/24);
• Easy Care First Aid 25 Person 2009 ANSI first aid kit (product 9999-2132), from lot W06H15 (Exp. 8/15/24);
• CVS First Aid Home first aid kit (product 2980-0700), from lot W06H15 (Exp. 8/15/24);
• Easy Care First Aid 25 Person 2009 ANSI first aid kit (product 9999-2132), from lot W06H15 (Exp. 8/15/24); and
• Easy Care First Aid 10 Person 2009 ANSI first aid kit (product 9999-2131), from lot W06H15 (Exp. 8/15/24).

GFA Production (Xiamen) Co voluntarily initiated the recall December 23, 2022. The FDA designated the recall Class I on January 27, 2023. 

Easy Care first aid AfterBurn Cream is an over-the-counter treatment for minor burns.