The Food and Drug Administration yesterday warned health care providers and consumers that certain hand sanitizers have tested positive for 1-propanol, including products made by Harmonic Nature S de RL de MI in Mexico.
“1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested,” FDA said.
The agency has expanded its list of do-not-use hand sanitizers to include products that contain or may contain this ingredient, and encourages providers and others to report adverse events or quality problems associated with hand sanitizers to its MedWatch program.
In other news, FDA recently approved for marketing in the U.S. a surgical gown (K200977) and three polymer patient examination gloves (K201530, K201531, K193666), including for use during the COVID-19 pandemic. In addition, the agency authorized for emergency use molecular tests made by LumiraDx UK Ltd. and Biomeme Inc. to detect SARS-CoV-2. Laboratories certified to perform high-complexity tests under the Clinical Laboratory Improvement Amendments of 1988 may use the tests.