NDC 61919-311
Lovastatin 10 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-467.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it and relabels it
Recalls
- Feb 13, 2019 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Lots: Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 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
- Lovastatin: every company that makes it
- Form
- tablet
- Strength
- 10 mg
- Approval
- ANDA ANDA078296
- On the market since
- Jan 1, 2014
- Package NDCs
61919-311-3061919-311-6061919-311-90- Official label
- DailyMed (National Library of Medicine), updated Apr 18, 2023
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