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 II2018-10-19
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was d

Top Reported Reactions

1
DRUG INEFFECTIVE
18,174 reports
2
FATIGUE
17,575 reports
3
PAIN
15,317 reports
4
OFF LABEL USE
13,526 reports
5
HEADACHE
12,436 reports
6
NAUSEA
11,400 reports
7
RASH
10,971 reports
8
DYSPNOEA
10,944 reports
9
ARTHRALGIA
10,121 reports
10
RHEUMATOID ARTHRITIS
9,640 reports