NDC 72189-012
Losartan Potassium And Hydrochlorothiazide 50 mg / 12.5 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-468.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 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
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 ANDA091629
- On the market since
- Jul 17, 2019
- Package NDCs
72189-012-90- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2025
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