NDC 33342-051

Losartan potassium and Hydrochlorothiazide 100 mg / 12.5 mg tablet, film coated

On the label: Macleods Pharmaceuticals Limited.

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

Recalls

May 7, 2024 · Class II · Macleods Pharma Usa, Inc
Presence of foreign substance: plastic-like substance.
Lots: Lot #: BLK2304A, Exp. 07/31/2025
Jun 10, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLM2114A, exp. date 07/2023
Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLK2107B, exp. date 05/2023 BLK2101A, exp. date 01/2025 BLK2102A, exp. date 02/2025 BLK2103B, exp. date 02/2023 BLK2103C, exp. date 02/2023 BLK2104A, 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 # BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2023 BLM2103B, exp. date 02/2023 BLM2104A, exp. date 05/2023 BLM2110A, exp. date 06/2023
Apr 15, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, 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: BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
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: BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19
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: BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21

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

Product details

Generic drug: Hydrochlorothiazide and Losartan: every company that makes it
Form: tablet, film coated, oral
Strength: 100 mg / 12.5 mg
Approval: ANDA ANDA202289
On the market since: May 3, 2012
Package NDCs: 33342-051-07 33342-051-10 33342-051-12 33342-051-44
Official label: DailyMed (National Library of Medicine), updated Jul 21, 2025

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