DABIGATRAN ETEXILATE
Generic: DABIGATRAN ETEXILATE
DABIGATRAN ETEXILATE is FDA application ANDA207961, sponsored by HETERO LABS LTD III. 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
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance t
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance t