NDC 72189-167
Losartan Potassium And Hydrochlorothiazide 100 mg / 12.5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-216.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- May 5, 2022 · Class II · Direct Rx
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22 - Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # H001149 4/30/2022 68180-215-06 H001602 5/31/2022 68180-215-06 H001884 6/30/2022 68180-215-06 H002539 8/31/2022 68180-215-06 H100944 4/30/2023 68180-215-06 H101054 4/30/2023 68180-215-06 H001150 4/30/2022 68180-215-09 H001151 4/30/2022 68180-215-09 H001152 4/30/2022 68180-215-09 H001… - Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/2022 68180-217-06 H101826 7/31/2023 68180-217-06 H001155 4/30/2022 68180-217-09 H001355 5/31/2022 68180-217-09 H001356 5/31/2022 68180-217-09 H001357 5/31/2022 68180-217-09 H001… - Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: Lot # H001878 6/30/2022 68180-216-06 H002178 7/31/2022 68180-216-06 H002626 9/30/2022 68180-216-06 H102149 9/30/2023 68180-216-06 H001600 5/31/2022 68180-216-09 H001601 5/1/2022 68180-216-09 H001625 5/31/2022 68180-216-09 H001626 5/31/2022 68180-216-09 H001794 6/30/2022 68180-216-0…
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, oral
- Strength
- 100 mg / 12.5 mg
- Approval
- ANDA ANDA078245
- On the market since
- Jan 8, 2021
- Package NDCs
72189-167-3072189-167-90- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2025
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