SACUBITRIL AND VALSARTAN
Generic: SACUBITRIL AND VALSARTAN
SACUBITRIL AND VALSARTAN is FDA application ANDA213604, sponsored by TORRENT. 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
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in t
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in t
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in t
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam