NDC 33342-190
AMLODIPINE and OLMESARTAN medoxomil 5 mg / 20 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
- Feb 15, 2022 · Class II · Macleods Pharma Usa Inc
cGMP deviations
Lots: Lot#: BAD62101A, Exp 2/2024 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: BAD62005A
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amlodipine and Olmesartan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg / 20 mg
- Approval
- ANDA ANDA206884
- On the market since
- Oct 27, 2016
- Package NDCs
33342-190-0733342-190-1033342-190-1233342-190-44- Official label
- DailyMed (National Library of Medicine), updated Jan 3, 2026
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