NDC 61919-708
Pravastatin Sodium 40 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Accord Healthcare Inc.'s NDC 16729-010.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) R2201093, Exp. Date 4/30/2024; b) R2201222, R2201231, Exp. Date 4/30/2024; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a )R2200589, R2200689, R2200690, R2201232, Exp. Date 4/30/2024 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: R2201294, Exp. Date 8/31/2025 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: R2201233, Exp. Date 4/30/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pravastatin: every company that makes it
- Form
- tablet, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA207068
- On the market since
- Jan 15, 2019
- Package NDCs
61919-708-30- Official label
- DailyMed (National Library of Medicine), updated Jan 10, 2024
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