NDC 53002-0151
Triamcinolone Acetonide 5 mg per 1 g ointment
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Teligent Pharma, Inc.'s NDC 52565-048.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Teligent Pharma, Inc. | Buena, New Jersey, United States | Makes it | Serious problems, FDA actionAug 31, 2021 · 8 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Lots: Batch: 15608, Exp. 5/31/2022; 16026, Exp. 9/30/2022; 16224, Exp. 11/30/2022
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
- ointment
- Strength
- 5 mg per 1 g
- Approval
- ANDA ANDA208590
- On the market since
- Mar 3, 2017
- Package NDCs
53002-0151-1- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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