NDC 33342-050
Losartan potassium and Hydrochlorothiazide 50 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
- 50 mg / 12.5 mg
- Approval
- ANDA ANDA202289
- On the market since
- Sep 10, 2012
- Package NDCs
33342-050-0733342-050-1033342-050-1233342-050-44- Official label
- DailyMed (National Library of Medicine), updated Jul 21, 2025
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