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Client Alert- FDA Issues Additional Warnings on Contaminated Hand Sanitizers

Aug 21, 2020
  • FisherBroyles News
  • Health Care
  • Pharmacy Law

With the onset of the COVID-19 pandemic earlier this year, hand sanitizers have become big business. Companies across the United States and abroad have ramped up hand sanitizer production in order to capitalize on consumer demand for the products. Other companies are purchasing these products in bulk for repackaging, distribution, and sale. Unfortunately, many of these products have been found to contain dangerous chemicals, including methanol and, in the FDA’s most recent warning, 1-propanol, which can be toxic and life-threatening when ingested. In other cases, hand sanitizers have failed to contain sufficient quantities of ethyl alcohol, isopropyl alcohol, or benzalkonium chloride, rendering them insufficient for use as sanitizer.

More than 150 hand sanitizer products from nearly 50 manufacturers in Mexico, China, and the United States are now on the FDA warning list.

Companies engaged in the purchase of hand sanitizers for the purpose of relabeling/repackaging and subsequent distribution for sale to consumers should proceed with caution. Given the ever-increasing number of manufacturers and distributors on the warning list, hand sanitizer distributors should assume that they now have a duty to test ALL hand sanitizer purchased for repackaging and distribution from every source. Assurances from manufacturers that hand sanitizer products meet FDA requirements should not be accepted at face value. Put plainly, distributors must make sure that products are precisely what they claim to be or face potential liability down the road for the distribution of toxic sanitizer products that can lead to serious injury or loss of life.

The FisherBroyles Pharmacy and Health Care Law team is pleased to keep those in the industry updated on topics of interest. Questions regarding the subject matter of this alert may be directed to any of the following:

Brian E. Dickerson  [email protected]    202.570.0248

Anthony J. Calamunci  [email protected]   419.376.1776

Nicole Hughes Waid  [email protected]   202.906.9572

Amy L. Butler  [email protected]   419.340.8466

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