LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Generic: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Teva Pharmaceuticals USAManufacturer
ORALRoute
LOSARTAN POTASSIUMActive Substance
2010-04-06Original Approval

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE is FDA application ANDA077157, sponsored by TEVA PHARMS. 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 II2022-04-15
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-cou

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class II2022-03-31
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-c

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class II2019-06-20
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active p

Class II2014-07-11
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: J

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Class II2022-04-15
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-coun

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class II2022-05-05
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceutica

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class II2022-03-31
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-cou

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class II2024-05-07
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Mac

Presence of foreign substance: plastic-like substance.

Class II2022-05-11
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Class II2022-03-31
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-co

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Top Reported Reactions

1
NAUSEA
113 reports
2
FATIGUE
110 reports
3
DIARRHOEA
98 reports
4
DRUG INEFFECTIVE
95 reports
5
HEADACHE
94 reports
6
DYSPNOEA
75 reports
7
ASTHENIA
74 reports
8
DIZZINESS
70 reports
9
BLOOD PRESSURE INCREASED
65 reports
10
ARTHRALGIA
57 reports