Agency classClass IOur severity:Critical FDA (Drugs)·D-0244-2023·Announced 2023-02-08

Easy Care first aid burn cream recalled for microbial contamination

Easy Care first aid burn cream distributed nationwide and in Canada is recalled due to FDA-detected contamination with Bacillus lichenformis and Bacillus sonorensis. The product should not be used.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I recall designation. Per the severity rubric, FDA Class I recalls are classified as Critical, the highest severity level.

Plain-English summary

Easy Care first aid burn cream (0.9 g packets containing benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%) packaged in boxes of 10 has been recalled. The product, identified as NDC 90107-0210 and manufactured by GFA Production Xiamen Co. Ltd. for Adventure Ready Brands, was distributed nationwide in the United States and to Canada.

FDA laboratory testing identified contamination with Bacillus lichenformis and Bacillus sonorensis in the product. These microbial contaminants pose a health risk in non-sterile products, particularly when applied to open wounds or damaged skin.

The affected product (Lot # W06I28, expiration 09/28/2024) comprises 2880 packets. Consumers should stop using this product immediately. Anyone who has used the product and has health concerns should contact a healthcare provider.

The recalled product

Product: Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product #…
Manufacturer: GFA Production Xiamen Co. Ltd.
Category: Drug — First Aid / Topical
Hazard: microbial-contamination
Affected units: 2,880

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # W06I28
exp 09/28/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by GFA Production Xiamen Co. Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · GFA Production Xiamen Co. Ltd.

See all →

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