Key Takeaway

AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. by NingBo Huize Commodity Co.,Ltd. was recalled on April 1, 2019. The hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDA Drug Class III Terminated

AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

Recalled: April 1, 2019 ~20,160 units affected D-1547-2019

Description

AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

Hazard / Reason

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

Drugs

Company Information

NingBo Huize Commodity Co.,Ltd.

Yuyao, N/A, China

View all 36 recalls by NingBo Huize Commodity Co.,Ltd. →

Distribution

Foreign manufacturer located in China and distributed to seven consignees located in China.

Related Recalls

Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

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Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

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