BUPROPION HYDROCHLORIDE SR
Generic: BUPROPION HYDROCHLORIDE
Solco Healthcare US LLCManufacturer
ORALRoute
BUPROPION HYDROCHLORIDEActive Substance
2015-05-26Original Approval
BUPROPION HYDROCHLORIDE SR is FDA application ANDA202304, sponsored by PRINSTON INC. 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 III2018-03-15
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-Failed Dissolution Specifications; during stability testing
Class III2018-03-15
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. Failed Dissolution Specifications; during stability testing
Top Reported Reactions
1
DRUG INEFFECTIVE
1,943 reports
2
HEADACHE
1,434 reports
3
DEPRESSION
1,336 reports
4
FATIGUE
1,329 reports
5
NAUSEA
1,158 reports
6
OFF LABEL USE
1,028 reports
7
PAIN
938 reports
8
ANXIETY
867 reports
9
DRUG INTERACTION
861 reports
10
RASH
816 reports