NDC 53002-9202
Fluocinonide 0.5 mg per 1 g cream
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1386.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharma Canada Inc. | Brampton, Canada | Makes it | No problems foundMar 27, 2026 · 7 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Mar 25, 2026 · Class II · Sun Pharmaceutical Industries Inc
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Lots: Lot# AD76252, Exp Date: 6/30/2026. - Mar 25, 2026 · Class II · Sun Pharmaceutical Industries Inc
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Lots: Lot# AD76251, Exp Date: 6/30/2026. - Mar 25, 2026 · Class II · Sun Pharmaceutical Industries Inc
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Lots: Lot# AD76250, Exp Date: 6/30/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluocinonide: every company that makes it
- Form
- cream
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA071500
- On the market since
- Oct 27, 2016
- Package NDCs
53002-9202-153002-9202-2- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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