FDA MedWatch – Easy Care First Aid Burn Cream and First Aid Kits by GFA Production (Xiamen)

TOPIC: Easy Care First Aid Burn Cream and First Aid Kits by GFA Production (Xiamen): Recall – Due to Microbial Contamination

AUDIENCE: Consumer, Patient, Dermatology, Pharmacy

ISSUE: GFA Production (Xiamen) is recalling one lot of Easy Care first aid AfterBurn Cream, 0.9 g single-use packets because FDA analysis found the product to be contaminated with Bacillus licheniformis, and Bacillus sonorensis. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. 

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) has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: 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. 

RECOMMENDATIONS: 

• Consumers should stop using the Easy Care first aid AfterBurn Cream 0.9 g single-use packet and discard it.

• 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.

• Consumers with questions regarding this recall can contact the company by email.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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