NDC 71205-458
Olmesartan Medoxomil 20 mg tablet, coated
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Ascend Laboratories, LLC's NDC 67877-446.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Baddi Solan, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Apr 29, 2021 · Class III · Ascend Laboratories LLC
Presence of Foreign Tablet/Capsule
Lots: Batch No. 20122548, Exp Date: Aug. 2022 - Jan 24, 2020 · Class II · Ascend Laboratories LLC
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Lots: Lot #: 19122552, Exp 7/31/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Olmesartan: every company that makes it
- Form
- tablet, coated, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA206763
- On the market since
- Apr 24, 2017
- Package NDCs
71205-458-30- Official label
- DailyMed (National Library of Medicine), updated Nov 1, 2024
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