Agency classClass IOur severity:Critical FDA (Drugs)·D-0246-2023·Announced 2023-02-08

First Aid Kit with Burn Cream Recalled for Bacterial Contamination

GFA Production is recalling Adventure First Aid 1.0 kits containing Easy Care After Burn Cream due to confirmed bacterial contamination found in FDA testing. The affected product was distributed nationwide and in Canada.

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 classification for confirmed bacterial contamination in a non-sterile topical product. Per the rubric, FDA Class I status mandates the highest severity score, indicating a serious health hazard.

Plain-English summary

GFA Production Xiamen Co. Ltd. is recalling Adventure First Aid 1.0 First Aid Kits containing Easy Care After Burn Cream 0.9 g packets due to confirmed contamination with Bacillus lichenformis and Bacillus sonorensis. FDA laboratory testing identified microbial contamination in the non-sterile product, triggering a Class I recall.

The recall affects 60,048 packets distributed nationwide and in Canada. The affected lot numbers are W06C05 (expiration 03/05/2024), W06F10 (expiration 06/10/2024), and W06H15 (expiration 08/15/2024). The product number is 0120-0213.

Consumers should contact GFA Production Xiamen Co. Ltd. for information regarding this recall.

The recalled product

Product: Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
Manufacturer: GFA Production Xiamen Co. Ltd.
Category: Drug — Topical Cream
Hazard: bacterial-contamination
bacillus-lichenformis
bacillus-sonorensis
Affected units: 60,048

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 (6)

Lot #: W06C05
exp 03/05/2024
W06F10
exp 06/10/2024
W06H15
exp 08/15/2024.

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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First Aid Kit Product Recalled Due to Bacterial Contamination
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Same hazard · bacterial contamination