NDC 53002-9334
triamcinolone acetonide 1 mg per 1 g cream
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Teligent Pharma, Inc.'s NDC 52565-056.
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: a) 15123, Exp. 2/28/2022; 15875, Exp. 8/31/2022; 16115, Exp. 10/31/2022; b) 15123, 15201, Exp. 2/28/2022; 15477, Exp. 4/30/2022; 15897, Exp. 8/31/2022; 16090, Exp. 10/31/2022; 16374, Exp. 1/31/2023; 16676, Exp. 3/31/2023; 17109, Exp. 7/31/2023; c) 15241, Exp. 2/28/2022; 16610, Exp. 3/31/2023…
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 ANDA208848
- On the market since
- Apr 17, 2017
- Package NDCs
53002-9334-2- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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