Harmonic Nature is recalling all 800 bottles of Hand Sanitizer due to the potential presence of 1-propanol, according to a statement published by the U.S. Food & Drug Administration.
The Mexico-based company said the products have been tested and found to contain 1 propanol. Harmonic Nature is yet to receive any confirmed reports of adverse events involving the product.
The company noted that 1-propanol with a concentration greater than or equal to 1 percent by volume that is unlisted in a product labeled as an ethanol-based hand sanitizer may cause acute toxicity from ingestion and lead to central nervous system depression. This could also lead to death, permanent impairment, or necessitate medical or surgical intervention, it added.
The maximum risk is to individuals with alcohol addiction and adolescents, who ingest ethanol-based antiseptic rubs intentionally to become intoxicated. Further, infants and children also may unintentionally ingest the defective product.
The recall involves hand sanitizer Topical Solution packaged in 250 mL plastic bottles, with UPC Code 7500462892210. They were distributed only to and currently on hold at the US custom bróker, Aquiles INC.
Harmonic Nature is notifying Aquiles INC. and is arranging for return of all recalled product.
Last week, another Mexican company Nanomateriales also recalled all lots of Zanilast+ GEL, Sanitizer gel, after the FDA laboratory analysis found that it contained 1-propanol.
The FDA has continued to recall hand sanitizers, primarily made in Mexico, under different brand names that have proliferated the market since the beginning of the ongoing coronavirus pandemic. All these were recalled for the potential presence of undeclared menthol or 1-propanol.
A month ago, the agency had warned consumers and healthcare workers against hand sanitizers with methanol which is cheaper than ethanol, a disinfectant. Methanol is toxic when absorbed through the skin and can be fatal if ingested.
The regulator has detained certain hand sanitizers from entering the U.S. market by placing them on import alert, on safety concerns.
The FDA first warned about methanol-containing hand sanitizers being sold in June. It issued a further warning in mid-July about the rising number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death. According to the regulator, the figures continue to increase.
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