LOSARTAN POTASSIUM

Generic: LOSARTAN POTASSIUM

Macleods Pharmaceuticals LimitedManufacturer
ORALRoute
LOSARTAN POTASSIUMActive Substance
2012-05-30Original Approval

LOSARTAN POTASSIUM is FDA application ANDA202230, sponsored by MACLEODS PHARMS 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 II2022-04-15
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-1

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

Class II2019-02-28
Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the act

Class II2022-04-15
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044

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

Class II2022-03-31
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378

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

Class II2019-02-28
Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the act

Class II2019-02-28
Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the act

Class II2022-04-15
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-

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

Class II2022-06-06
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.

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

Class II2022-06-06
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, In

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

Class II2019-06-20
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08

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

Top Reported Reactions

1
FATIGUE
12,579 reports
2
DIARRHOEA
10,542 reports
3
NAUSEA
9,797 reports
4
DRUG INEFFECTIVE
9,744 reports
5
DYSPNOEA
8,935 reports
6
DIZZINESS
8,497 reports
7
HEADACHE
8,433 reports
8
PAIN
7,730 reports
9
OFF LABEL USE
7,645 reports
10
ARTHRALGIA
6,681 reports