VALSARTAN AND HYDROCHLOROTHIAZIDE

Generic: VALSARTAN AND HYDROCHLOROTHIAZIDE

Lupin PharmaceuticalsManufacturer

ORALRoute

HYDROCHLOROTHIAZIDEActive Substance

2013-03-21Original Approval

VALSARTAN AND HYDROCHLOROTHIAZIDE is FDA application ANDA078946, sponsored by LUPIN 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 II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

Class II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

Class II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottle

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

Class II2018-07-13

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class II2018-07-13

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufacture

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

Class II2018-11-20

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in t

Class II2018-12-31

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in

Class II2018-12-31

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in

Class II2018-12-31

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharm

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in

VALSARTAN AND HYDROCHLOROTHIAZIDE

Recalls

Top Reported Reactions