NDC 83008-019
Diclofenac sodium 20 mg per 1 g solution
On the label: Lake Erie Medical DBA Quality Care Products LLC. It's repackaged: Lake Erie Medical DBA Quality Care Products LLC rebottles it from Alembic Pharmaceuticals Inc.'s NDC 62332-487.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | Vadodara, India | Makes it and tests it | No problems foundMar 10, 2023 · 2 inspections |
Repackaging site
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC, Location not on file · relabels it
Recalls
- Jun 22, 2023 · Class II · Alembic Pharmaceuticals, Inc.
Defective Delivery System
Lots: Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diclofenac: every company that makes it
- Form
- solution, topical
- Strength
- 20 mg per 1 g
- Approval
- ANDA ANDA212506
- On the market since
- May 2, 2023
- Package NDCs
83008-019-12- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2024
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