IRBESARTAN

Generic: IRBESARTAN

Lupin PharmaceuticalsManufacturer
ORALRoute
IRBESARTANActive Substance
2012-10-15Original Approval

IRBESARTAN is FDA application ANDA201531, 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 II2019-01-18
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,

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

Class II2019-01-18
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhe

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

Class II2021-10-12
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Class II2019-01-18
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,

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

Class II2021-10-12
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Class II2019-01-18
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmace

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

Class II2021-10-12
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Class III2016-05-30
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical C

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the

Class II2022-07-18
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Indi

Failed Dissolution Specifications

Class III2015-10-20
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TE

Labeling: Incorrect or Missing Lot AND/OR Exp Date.

Top Reported Reactions

1
ACUTE KIDNEY INJURY
2,022 reports
2
FATIGUE
1,789 reports
3
NAUSEA
1,730 reports
4
DIARRHOEA
1,720 reports
5
FALL
1,573 reports
6
OFF LABEL USE
1,479 reports
7
DYSPNOEA
1,469 reports
8
DRUG INEFFECTIVE
1,428 reports
9
HEADACHE
1,353 reports
10
DIZZINESS
1,307 reports