artnaturals® Issues Voluntary Recall of Limited Batches of 8oz Bottles of Scent Free Hand Sanitizer Due to Presence of Impurities

Summary

Company Announcement

artnaturals is voluntarily recalling ten manufacturing lots of artnaturals 8oz Scent Free Hand Sanitizer. FDA testing identified 8oz bottles of Scent Free Hand Sanitizer from a single manufacturing lot: G20128A, contained several impurities. Upon being contacted by the FDA, artnaturals responded immediately to proactively address the matter out of an abundance of caution. After multiple communications with the FDA, the two groups have mutually agreed that artnaturals will issue a voluntary recall of 10 manufacturing lots of 8oz Scent Free Hand Sanitizer.

Exposure to the impurities found can happen naturally in our surrounding environments through inhalation, oral consumption and skin absorption. Long term exposure could result in cancers-including leukemia, cancer of the bone marrow and blood disorders. To date, artnaturals has not received any reports of adverse events related to this voluntarily recalled product.

The product is used to remove germs on hands that may cause illness when soap and water are not available and is packaged in 8 oz clear bottles. The voluntarily recalled ten manufacturing lots of artnaturals 8oz bottles of SCENT FREE hand sanitizer are as follows:

The product can be identified by the pictures below.

Product purchased from Walmart, Target, Costco, RiteAid, Publix, HEB and Amazon were not affected. artnaturals has notified the affected retailer by letter and arranged a return of all affected product. Consumers that have this recalled product should stop using and appropriately discard it.

Consumers may contact artnaturals Customer Experience with questions or to request a refund by calling 1-855-278-4488 Mon-Fri, 8am-5pm Pacific Time. Consumers should contact their physician or healthcare provider if they have any questions or concerns related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.