Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs

Recall Number: D-0787-2023

Firm: Akorn, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20230607

Initiation Date: 20230426

Termination Date:

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs