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Public Alert No.0040/2021 – FDA Updates On Hand Sanitizers Consumers Should Not Use: Update – CDER Alert

October 21, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration (FDA) about a safety communication that the agency has tested certain artnaturals scent free hand sanitizer labeled with “DIST. by artnaturals Gardena, CA 90248” and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to the list of hand sanitizers consumers should not use.

To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination.

Benzene is absorbed through the skin and may cause cancer in humans. Animal studies shows that acetaldehyde containing benzene may cause serious illness or death.

Acetaldehyde can irritate the upper respiratory tract, eyes, and skin. While the exact risk from using hand sanitizer containing benzene, acetaldehyde, is unknown

PRODUCT DETAILS

Product name NDC SIZE MARKETING START DATE
artnaturals scent free hand sanitizer labeled with “DIST 74642-000-01

 

236ML 04/08/2020

PRODUCT IMAGES

RECOMMENDATIONS

NAFDAC implores importers, distributors, healthcare professionals, and consumers in possession of artnaturals scent free hand sanitizer labeled with “DIST. to discontinue sale or use and handover remaining stock to the nearest NAFDAC office.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of these medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores. 

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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