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  1. Enforcement Activities | FDA

FDA notification regarding dehydrated alcohol

 

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:

Drug NDC

Product name

17478-503
17478-825

Dehydrated alcohol

0517-8571
0517-8575

Dehydrated alcohol

71414-305
71414-301

Dehydrated alcohol

13925-177

Dehydrated alcohol

52584-575
52584-503

Dehydrated alcohol

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.