Product: 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
Reason for recall: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated: 20230426
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated