AZELASTINE HYDROCHLORIDE

Generic: AZELASTINE HYDROCHLORIDE

YYBA CorpManufacturer

NASALRoute

AZELASTINE HYDROCHLORIDEActive Substance

2025-01-27Original Approval

AZELASTINE HYDROCHLORIDE is FDA application ANDA216561, sponsored by AUROBINDO PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2018-02-05

Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical

Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failu

Class II2025-05-28

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,

Lack of Assurance of Sterility

Class III2011-06-15

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., To

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.