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Sanitizer Recalls Expanded Due to 1-Propanol

The FDA regularly posts updates on recalls, outbreak investigations, and related regulatory activities. Weekly, we identify which of those announcements might be most clinically relevant.

The US Food and Drug Administration (FDA) has continued recalls of hand sanitizers which have proliferated since the start of the SARS-CoV-2 pandemic.

The FDA regularly posts updates on recalls, outbreak investigations, and related regulatory activities like these. Weekly, we identify which of those announcements might be most clinically relevant.

The following are related to the investigation of 1-propanol in hand sanitizer products.

(Below are excerpts taken from official FDA postings)

Harmonic Nature Issues Voluntary Nationwide Recall of Hand Sanitizer Due to the Presence of 1-Propanol

Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol.

Risk Statement: Any amount of 1-propanol with a concentration greater than or equal to 1% by volume that is unlisted in a product labeled as an ethanol-based hand sanitizer has a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product. Harmonic Nature has not received any reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in 250 mL plastic bottles , with UPC Code 7500462892210. The product can be identified by Harmonic Nature as a hand sanitizer Topical Solution distributed only to and currently on hold at the US custom bróker, Aquiles INC.

Nanomateriales, SA de CV Issues Voluntary Nationwide Recall of All Lots of Zanilast+gel Due to the Presence of 1-Propanol

Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol.

Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product. Nanomateriales, SA de CV has not received any reports of adverse events related to this recall.

The product is used as a sanitizer gel, for hand washing to decrease bacteria on the skin and is packaged in 1 liter, 25 kg, and 1 gallon plastic bottles distributed from 05/29/2020 to 06/17/2020 in the States of California, New York and New Jersey.