NDC 53002-9330
Triamcinolone Acetonide 1 mg per 1 g cream
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Padagis Israel Pharmaceuticals Ltd's NDC 45802-064.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | Yeruham, Israel | Makes it | No problems foundOct 27, 2022 · 6 inspections |
| Padagis US LLC | Minneapolis, MN, United States | Makes it | Problems found, fixed voluntarilyApr 8, 2026 · 12 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Recalls
- Aug 17, 2022 · Class II · Padagis US LLC
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Lots: Lot 2CT0486 , Exp 02/29/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Triamcinolone Acetonide: every company that makes it
- Form
- cream
- Strength
- 1 mg per 1 g
- Approval
- ANDA ANDA086413
- On the market since
- Sep 28, 2006
- Package NDCs
53002-9330-153002-9330-2- Official label
- DailyMed (National Library of Medicine), updated Feb 19, 2020
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