Akorn, Inc. recalls Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-
Recalled June 7, 2023 · FDA recall D-0787-2023 · Akorn
Hazard
CGMP Deviations: Firm went out of business and could no longer continue stability studies. · FDA Class II
Units
N/A
Sold at
Nationwide in the USA and Puerto Rico
Description
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →