NDC 68462-324
ezetimibe and simvastatin 10 mg / 80 mg tablet
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- May 19, 2025 · Class III · Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Lots: Lot #: 17240195, Exp 01/31/2026. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 17201603
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ezetimibe and Simvastatin: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg / 80 mg
- Approval
- ANDA ANDA208699
- On the market since
- Jun 27, 2019
- Package NDCs
68462-324-0568462-324-3068462-324-90- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2024
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