NDC 33342-046

Losartan potassium 100 mg tablet, film coated

Where it's made

Factory	Where	Role	Last FDA inspection
Macleods Pharmaceuticals Limited	District Solan, India	Makes it, tests it, packages it and labels it	Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action

Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022
Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023
Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023
Jun 20, 2019 · Class II · Macleods Pharma Usa Inc
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Lots: BLI711A Nov 2019
Jun 20, 2019 · Class II · Macleods Pharma Usa Inc
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Lots: BLI710A Nov 2019

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Losartan: every company that makes it
Form: tablet, film coated, oral
Strength: 100 mg
Approval: ANDA ANDA202230
On the market since: Jun 1, 2012
Package NDCs: 33342-046-07 33342-046-10 33342-046-12 33342-046-44
Official label: DailyMed (National Library of Medicine), updated Jul 28, 2025

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