NDC 53002-9970
Clobetasol Propionate 0.5 mg per 1 g ointment
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1259.
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 |
| Taro Pharmaceutical Industries Ltd. | Haifa Bay, Israel | Makes it | No problems foundDec 8, 2022 · 7 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Dec 15, 2021 · Class I · Taro Pharmaceuticals U.S.A., Inc.
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Lots: Lot# AC13786, exp. date DEC 2022 - Dec 21, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications
Lots: Lot 311235, exp Sept 2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clobetasol: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA074248
- On the market since
- Jul 12, 1996
- Package NDCs
53002-9970-153002-9970-2- Official label
- DailyMed (National Library of Medicine), updated Jan 31, 2023
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