NDC 76420-124
Pregabalin 300 mg capsule
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Rising Pharma Holdings, Inc.'s NDC 64980-417.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Laurus Labs Limited | Anakapalli, India | Makes it and tests it | Problems found, fixed voluntarilyFeb 10, 2023 · 2 inspections |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it
Recalls
- May 16, 2024 · Class III · Rising Pharma Holding, Inc.
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Lots: Lot: 23132611, Exp 07/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pregabalin: every company that makes it
- Form
- capsule, oral
- Strength
- 300 mg
- Approval
- ANDA ANDA210432
- On the market since
- Jul 19, 2019
- Package NDCs
76420-124-3076420-124-6076420-124-90- Official label
- DailyMed (National Library of Medicine), updated Jun 25, 2020
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