Recalls & Warnings
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Posted April 27, 2022
FDA Tests Find Imported Hand Sanitizer Contains Less Active Ingredient Than Claimed
On April 19th, 2022, the FDA issued a warning letter to Guangzhou Zhongkebaishi Health Industry Co., Ltd. following FDA laboratory testing, which found the company’s Hand Sanitizer Gel contained less ethanol (the active ingredient) than listed on the label, and less ethanol than recommended by the CDC for hand sanitizers.
Guangzhou’s Hand Sanitizer Gel is labeled as containing 75% ethanol, but was found by FDA testing to contain only 51% ethanol. The CDC recommends that consumers use alcohol-based hand sanitizer products with no less than 60% ethanol.
The FDA also warned that the product label includes the FDA logo to create the impression that the drug is approved by the agency. The label fails to meet labeling requirements and does not disclose a domestic address or telephone number on product labeling in case of serious adverse events, which is required by federal regulations.
The company is required to respond in writing to the FDA within 15 days to provide information about why the hand sanitizer contains less ethanol than listed, and a list of all batches of the product that were shipped to the U.S.
Learn more about hand sanitizers in ConsumerLab’s article about coronavirus and disinfection.
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