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FDA's Sanitizer Hotlist Cites Nevada Distributor, Calls Out Subpotency and Methanol

Contact Author Rachel Grabenhofer
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This report is an update on the U.S. Food and Drug Administration's (FDA's) running hotlist of concerning hand sanitizers consumers are cautioned to not use.

As previously noted, the FDA's list flags hand sanitizer products implicated or known for methanol and 1-propanol content or subpotent efficacy, among other complaints. Last quarter (October 2020), several products were added from China. This quarter includes more additions from China and Mexico, along with one Nevada, USA distributor.

See related: How NOT to Formulate Hand Sanitizers

The following companies and products appeared on the FDA's list between Nov. 10, 2020, and Jan. 11, 2021. For the complete list, see the FDA website.

  • Simex Logistics SA de CV (Mexico), for its Health & Hand Gel Hand Sanitizer, which was FDA-tested and found to contain subpotent ethanol alcohol levels. The FDA recommended a company recall on Nov. 10, 2020, and added the firm to an import alert to stop its products from entering the U.S. on Nov. 17, 2020. The product was voluntarily recalled on Nov. 25, 2020. In relation, the Protec Hands Antibacterial Gel, Topical Solution Non-sterile Solution, UVTWORLD Gel Hand Sanitizer, CitruGel Hand Sanitizer and LAVAR70 Gel Hand Sanitizer (from various distributors) were flagged for purported manufacturing at the same facility that produced the subpotent product. In response, these products were voluntarily recalled on Nov. 25, 2020.

  • Hou Fu Biotech (Jiansu) Co. Ltd. (China), for its PANROSA Instant Hand Sanitizer Aloe Vera, which was FDA-tested and found to contain subpotent ethanol alcohol levels. The FDA recommended a company recall on Nov. 12, 2020, and added an import alert to stop products from the company from entering the U.S. on Dec. 3, 2020. In relation, the manufacturer's EPH Labs Hand Sanitizer and PANROSA Instant Hand Sanitizer were listed for purportedly being made at the same facility that produced the subpotent ethanol alcohol-containing product.

  • Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico), for its Pristine Hand Sanitizer Gel, which was FDA-tested and found to contain subpotent ethanol alcohol levels. The FDA recommended a company recall on Nov. 20, 2020, and the product was voluntarily recalled on Dec. 1, 2020. The company was added to an import alert to stop its products from entering the U.S. on Dec. 22, 2020. In relation, the Zapien Productos Hand Sanitizer Gel was cited for purportedly being made at the same facility that produced the subpotent ethanol alcohol-containing product. The FDA recommended a company recall on Nov., 20, 2020, the product was voluntarily recalled on Dec. 8, 2020, and the company was added to an import alert to keep its products from entering the U.S. on Dec. 22, 2020.

  • Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China), for its IMC Wash-Free Hand Sanitizer, which was FDA-tested and found to contain methanol. The FDA has been unable to contact the manufacturer or distributor to recommend a recall, and the product was voluntarily recalled by Shane Erickson on Dec. 23, 2020. The manufacturer was added to an import alert to stop its products from entering the U.S. on Jan. 7, 2021. In relation, its Essentials, M.D. Hand Sanitizer Industrial and Hospital Grade, KLEAN KARE Hand Sanitizer Industrial and Hospital Grade, Yuame Wash-Free Hand Sanitizer Gel and Yuame 75% Alcohol Disinfectant Products were flagged for purportedly being made at the same facility that produced the methanol-contaminated product. The FDA has been unable to contact the manufacturer or distributor to recommend a recall and added the manufacturer to an import alert to stop its products from entering the U.S. on Jan. 7, 2021.

  • The distributor SBL Brands LLC (Nevada), for selling Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, which was FDA-tested and found to contain methanol. The FDA has been unable to determine the manufacturer or contact the distributor to recommend a recall. In relation, the Medically Minded Hand Sanitizer Gel Antimicrobial Formula and Formula with Vitamin E and Moisturizer were added to the hotlist as products possibly made at the same facility that produced the methanol-contaminated product. The FDA has been unable to determine the manufacturer or contact the distributor to recommend a recall.

  • Finally, Corporativo Bureli SA de CV (Mexico), for its SOHO Fresh Rubbing Alcohol, which was voluntarily recalled by Essaar Inc. due to methanol contamination on Jan. 4, 2021. The manufacturer was added to an import alert to stop its products from entering the U.S. on Sept. 24, 2020, and the FDA issued a warning letter on Dec. 1, 2020.
 

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