ETHAMBUTOL HYDROCHLORIDE

Generic: ETHAMBUTOL HYDROCHLORIDE

Lupin PharmaceuticalsManufacturer
ORALRoute
ETHAMBUTOL HYDROCHLORIDEActive Substance
2009-06-17Original Approval

ETHAMBUTOL HYDROCHLORIDE is FDA application ANDA078939, sponsored by LUPIN. 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 III2013-02-22
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,

Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specif

Top Reported Reactions

1
PRODUCT USE IN UNAPPROVED INDICATION
213 reports
2
PYREXIA
164 reports
3
NAUSEA
132 reports
4
VOMITING
123 reports
5
DRUG INTERACTION
114 reports
6
DRUG INTOLERANCE
105 reports
7
COUGH
94 reports
8
DYSPNOEA
93 reports
9
OFF LABEL USE
89 reports
10
DIARRHOEA
88 reports