NDC 72189-330
Triamcinolone Acetonide 1 mg per 1 g cream
On the label: Direct Rx. It's repackaged: Direct Rx 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
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Sep 12, 2022 · Class II · Direct Rx
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Lots: Lot: 12JY2216, Exp. 2/29/24 - 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, topical
- Strength
- 1 mg per 1 g
- Approval
- ANDA ANDA086413
- On the market since
- Mar 1, 2022
- Package NDCs
72189-330-80- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2025
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