DULOXETINE HYDROCHLORIDE
Generic: DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE is FDA application ANDA207219, sponsored by YAOPHARMA CO 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
Failed Dissolution Specification
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found i
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm,
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit