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FDA Flags 13 More Sanitizers, Issues One Warning for Methanol Content

Contact Author Rachel Grabenhofer
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Methanol content, or associations therewith, are cited as the reasons for 12 of the 13 latest additions by FDA to its 'do not use' hand sanitizer list.

This brings the total number of entries to 249 as of May 20, 2021. In addition, the administration issued one warning letter for a hand sanitizer disinfectant gel containing ~65% methanol that was detained at the U.S. border.

See related: 6 Sanitizer Offenses, Color Additives and Cosmetic Registrations; FDA Update

Additions to 'Do Not Use' List

Products added to the FDA's list of product violations include:

  • Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free, by Sanit Technologies LLC, doing business as Durisan (Florida)—for product testing that revealed microbial contamination. The product was recalled in March 2021 and this recall was expanded on May 14, 2021.

  • Fresh Lemon Citron Frais Scented Hand Sanitizer by Scentsational Soaps and Candles Inc. (Florida)—tested and found to contain methanol, benzene and acetaldehyde. The product was recalled late in April 2021 and this recall was expanded on May 10, 2021.

  • SS Black and White Collection and Photo Real Collection: Coconut Breeze, Eucalyptus & Mint, Lavender & Herbs, Lemon Zest and Tangerine & Guava by Scentsational Soaps and Candles Inc. (Florida)—all tested and found to contain methanol, benzene and acetaldehyde. The products were voluntarily recalled in late April 2021 and the recall was expanded on May 10, 2021.

  • Dibar Labs Hand Sanitizer (2 entries)—tested and found to contain methanol; product voluntarily recalled on May 11, 2021; ProtectoRx Hand Sanitizer Extra Strength (voluntarily recalled on May 11); Eztizer Hand Sanitizer (FDA recommended recall on April 27); Advance Hand Sanitizer (FDA recommended recall on April 27); Basic Care Gel Hand Sanitizer (FDA recommended recall on April 27); Genesis Today Advanced Hand Sanitizer (FDA recommended recall on April 27); Wellnicity Hand Sanitizer (FDA recommended recall on April 27); and Bklen Hands Sanitizer (FDA recommended recall on April 27)—all purported to be made at the same facility that produced a methanol-contaminated product. All products are by Dibar Nutricional S De RL de CV (Mexico).

  • Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution, also by Scentsational Soaps and Candles Inc. (Florida)—tested and found to contain methanol, benzene and acetaldehyde; voluntarily recalled in late April 2021 and recall expanded on May 10, 2021.

See related: ACI, CHPA Urge FDA to WIthdraw Allowance for Emergency Sanitizer Production

Warning Letter: Methanol Content

The FDA also issued one warning letter to C&G Laboratorios SA de CV, of Mexico, on April 26, 2021, for its antiseptic rub drug product labeled as Hand Sanitizer Disinfectant Gel. The product was detained at the U.S. border and refused admission.

According to the letter, "The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product manufactured at your facility is adulterated..." More specifically, the product was labeled to contain 70% v/v of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing found the drug product contained on average of 1.1% ethanol and an average of 65% methanol v/v.

Follow us as we continue to report on hand sanitizer developments and violations.

 

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