BROMPHENIRAMINE MALEATE

Generic: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE

PAI HoldingsManufacturer

ORALRoute

BROMPHENIRAMINE MALEATEActive Substance

2014-07-21Original Approval

BROMPHENIRAMINE MALEATE is FDA application ANDA202940, sponsored by PHARM ASSOC. 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.