Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Recalls
- Oct 22, 2021 · Class II · Sun Pharmaceutical Industries Inc
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Lots: Lot number: DNC0432A, expiration 01/2023
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 ANDA091157
- On the market since
- Dec 4, 2019
- Package NDCs
47335-693-0847335-693-1847335-693-8347335-693-88- Official label
- DailyMed (National Library of Medicine), updated Dec 21, 2023
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