AMLODIPINE AND VALSARTAN

Generic: AMLODIPINE AND VALSARTAN

Lupin PharmaceuticalsManufacturer
ORALRoute
AMLODIPINE BESYLATEActive Substance
2015-03-30Original Approval

AMLODIPINE AND VALSARTAN is FDA application ANDA090245, sponsored by LUPIN. 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 II2018-11-20
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pha

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

Class II2018-11-20
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Ph

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

Class II2018-11-20
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pha

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

Class II2018-12-04
Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm

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

Class II2018-12-31
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In

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

Class II2018-12-31
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,

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

Class II2018-12-04
Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm

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

Class II2018-12-31
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc

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

Class II2018-12-04
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharma

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

Class II2018-12-31
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In

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

Top Reported Reactions

1
PAIN
12 reports
2
OFF LABEL USE
11 reports
3
DRUG INEFFECTIVE
10 reports
4
SUICIDE ATTEMPT
10 reports
5
DRUG INTERACTION
9 reports
6
HYPERTENSION
9 reports
7
INTENTIONAL OVERDOSE
9 reports
8
PRODUCT USE IN UNAPPROVED INDICATION
9 reports
9
WEIGHT DECREASED
9 reports
10
ANAEMIA
8 reports