The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 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).
- Testing updates:
- To date, the FDA has currently authorized 212 tests under EUAs; these include 173 molecular tests, 37 antibody tests, and 2 antigen tests.
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