CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Generic: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sun Pharmaceutical IndustriesManufacturer
ORALRoute
CETIRIZINE HYDROCHLORIDEActive Substance
2012-09-28Original Approval

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is FDA application ANDA090922, sponsored by SUN PHARM INDS LTD. 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 II2021-03-15
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
SYSTEMIC LUPUS ERYTHEMATOSUS
5,380 reports
2
PAIN
5,368 reports
3
DRUG INEFFECTIVE
5,341 reports
4
RHEUMATOID ARTHRITIS
5,272 reports
5
PEMPHIGUS
5,255 reports
6
ABDOMINAL DISCOMFORT
5,151 reports
7
ALOPECIA
5,044 reports
8
GLOSSODYNIA
4,824 reports
9
FATIGUE
4,683 reports
10
WOUND
4,660 reports