PROPRANOLOL HYDROCHLORIDE

Generic: PROPRANOLOL HYDROCHLORIDE

Ipca Laboratories LimitedManufacturer
ORALRoute
PROPRANOLOL HYDROCHLORIDEActive Substance
2008-06-02Original Approval

PROPRANOLOL HYDROCHLORIDE is FDA application ANDA078955, sponsored by IPCA LABS 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 II2022-01-26
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Top Reported Reactions

1
OFF LABEL USE
1,777 reports
2
DRUG INEFFECTIVE
1,242 reports
3
NAUSEA
902 reports
4
PRODUCT USE IN UNAPPROVED INDICATION
863 reports
5
PRODUCT USE ISSUE
863 reports
6
HEADACHE
772 reports
7
FATIGUE
751 reports
8
TOXICITY TO VARIOUS AGENTS
660 reports
9
DIARRHOEA
608 reports
10
DRUG INTOLERANCE
588 reports