Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature, S de RL de MI, in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination.
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.
The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers. This list includes hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use.
Recently, the FDA issued warning letters to sellers because their tests were adulterated and misbranded: (AkivaMed Inc., CoreMedica Laboratories, Inc., Fair Price Labs, Inc., and Holistic Health International, LLC).
To date, the FDA has currently authorized 212 tests under EUAs; these include 173 molecular tests, 37 antibody tests, and 2 antigen tests.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.