WARFARIN SODIUM
Generic: WARFARIN SODIUM
Sun Pharmaceutical IndustriesManufacturer
ORALRoute
WARFARIN SODIUMActive Substance
1999-07-15Original Approval
WARFARIN SODIUM is FDA application ANDA040301, sponsored by TARO. 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
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany,CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi
Class II2022-01-26
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, ParsippanCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi
Class III2014-08-25
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical IndusFailed Content Uniformity Specifications.
Top Reported Reactions
1
INTERNATIONAL NORMALISED RATIO INCREASED
10,360 reports
2
DYSPNOEA
8,501 reports
3
DRUG INTERACTION
6,360 reports
4
FATIGUE
6,233 reports
5
NAUSEA
6,008 reports
6
DIARRHOEA
5,971 reports
7
DIZZINESS
5,209 reports
8
DRUG INEFFECTIVE
5,196 reports
9
FALL
4,854 reports
10
DEATH
4,761 reports