FEXOFENADINE HYDROCHLORIDE
Generic: FEXOFENADINE HYDROCHLORIDE
AMERISOURCE BERGENManufacturer
ORALRoute
FEXOFENADINE HYDROCHLORIDEActive Substance
2012-02-06Original Approval
FEXOFENADINE HYDROCHLORIDE is FDA application ANDA091567, sponsored by SUN PHARM INDS. 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 II2023-02-09
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847Failed Impurities/Degradation Specifications
Class II2024-01-18
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
Top Reported Reactions
1
DRUG INEFFECTIVE
803 reports
2
NAUSEA
468 reports
3
FATIGUE
438 reports
4
HEADACHE
437 reports
5
DIARRHOEA
431 reports
6
DIZZINESS
399 reports
7
PRURITUS
374 reports
8
DYSPNOEA
368 reports
9
PRODUCT QUALITY ISSUE
364 reports
10
RASH
325 reports