NDC 65862-163
Quinapril Hydrochloride/Hydrochlorothiazide 20 mg / 25 mg tablet, film coated
On the label: Aurobindo Pharma Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Recalls
- Oct 5, 2022 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Lots: Lots QE2021005-A and QE2021010-A, exp 01/2023
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 Quinaprilat: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 20 mg / 25 mg
- Approval
- ANDA ANDA078450
- On the market since
- Aug 24, 2007
- Package NDCs
65862-163-90- Official label
- DailyMed (National Library of Medicine), updated Apr 28, 2024
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