FEXOFENADINE HCL
Generic: FEXOFENADINE HCL, FEXOFENADINE HYDROCHLORIDE, ALLERGY RELIEF
Strategic Sourcing ServicesManufacturer
ORALRoute
FEXOFENADINE HYDROCHLORIDEActive Substance
2016-08-19Original Approval
FEXOFENADINE HCL is FDA application ANDA204097, sponsored by HETERO LABS LTD V. 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 III2022-01-04
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets Failed Dissolution Specifications
Class III2021-11-12
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets,Failed dissolution specifications
Class III2021-11-12
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, DistriFailed dissolution specifications
Class III2022-01-04
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-RelFailed Dissolution Specifications
Top Reported Reactions
1
DRUG INEFFECTIVE
796 reports
2
NAUSEA
465 reports
3
FATIGUE
437 reports
4
HEADACHE
433 reports
5
DIARRHOEA
429 reports
6
DIZZINESS
396 reports
7
PRURITUS
372 reports
8
DYSPNOEA
367 reports
9
PRODUCT QUALITY ISSUE
356 reports
10
RASH
323 reports