Multi-event December 2022 FDA Recall Drug by Gfa Production Xiamen Co. Ltd.

This Multi-event Class I drug recall was voluntarily initiated by Gfa Production Xiamen Co. Ltd. on December 23, 2022 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0250-2023 TERMINATED D-0246-2023 TERMINATED D-0244-2023 TERMINATED D-0251-2023 TERMINATED D-0253-2023 TERMINATED D-0248-2023 TERMINATED D-0249-2023 TERMINATED D-0245-2023 TERMINATED D-0252-2023 TERMINATED D-0247-2023 TERMINATED

Recall Number: D-0250-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
66400 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150

Batch or Lot Expiration Information

Lot# : W06C05, exp 03/05/2024; W06H15, exp 08/15/2024.

Recall Number: D-0246-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
60048 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213

Batch or Lot Expiration Information

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

Recall Number: D-0244-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
2880 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the 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 # 9999-1515

Batch or Lot Expiration Information

Lot# W06I28, exp 09/28/2024

Recall Number: D-0251-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
8280 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132

Batch or Lot Expiration Information

Lot# W06H15, exp 08/15/2024

Recall Number: D-0253-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
7200 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131

Batch or Lot Expiration Information

Lot# W06H15, exp 08/15/2024

Recall Number: D-0248-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
37464 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129

Batch or Lot Expiration Information

Lot# W05L28, exp 12/28/2023

Recall Number: D-0249-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
194460 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128

Batch or Lot Expiration Information

Lot# : W05L28, exp 12/28/2023; W06F10, exp 06/10/2024; W06H15, exp 08/15/2024.

Recall Number: D-0245-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
2016 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150

Batch or Lot Expiration Information

Lot# W06I20, exp. date 09/20/2024

Recall Number: D-0252-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
15000 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700

Batch or Lot Expiration Information

Lot# W06H15, exp 08/15/2024

Recall Number: D-0247-2023

Reason for Recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Initiated
12-23-2022
Reported
02-08-2023
Quantity
75381 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91410
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GFA Production Xiamen Co. Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212

Batch or Lot Expiration Information

Lot# W06H15, exp 08/15/2024