Stop distributing unapproved drugs included in kits
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits,” including:
- FIRST Lansoprazole
- FIRST Pantoprazole
- FIRST Metronidazole
- FIRST Mouthwash BLM
These kits have not been proven safe and effective and do not qualify for exemptions under the compounding provisions in sections 503A and 503B of the Federal Food, Drug and Cosmetic Act.
FDA encourages companies marketing unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drug marketed in the United States.
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Content current as of:
09/26/2024
