FDA notification regarding dehydrated alcohol

FDA requested companies stop distributing unapproved versions of dehydrated alcohol.

The agency approved Belcher Pharmaceuticals LLC’s Ablysinol (dehydrated alcohol), 1 mL and 5 mL ampules (NDC 62250-105) on June 21, 2018. All other dehydrated alcohol products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA, including:

FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drug marketed in the United States.