🍔 Food 💊 Drugs 🏥 Medical Devices
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3 Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9 Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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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 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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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 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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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 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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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 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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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 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213 Class I

Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

GFA Production Xiamen Co. Ltd. 20221223 Terminated
Distributed: Nationwide and Canada.
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