FDA-Drug2023-06-07Class II
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
Akorn, Inc.
Hazard
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
N/A
Manufactured in
5605 Centerpoint Ct Ste A, N/A, Gurnee, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0787-2023Don't want to check this manually?
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