NDC 65862-855
Amlodipine and Olmesartan Medoxomil 5 mg / 40 mg tablet, film coated
On the label: Aurobindo Pharma Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Nov 30, 2018 · Class III · Aurobindo Pharma USA Inc.
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Lots: Lot#: OWSA18002-A, Exp 7/2020
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 / 40 mg
- Approval
- ANDA ANDA206906
- On the market since
- May 15, 2017
- Package NDCs
65862-855-30- Official label
- DailyMed (National Library of Medicine), updated Apr 15, 2024
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