NDC 53002-3501
Indomethacin 50 mg capsule
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-543.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Jul 18, 2018 · Class II · Hetero Labs, Ltd. - Unit III
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Lots: Lot #: E180315, Exp 12/19
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Indomethacin: every company that makes it
- Form
- capsule
- Strength
- 50 mg
- Approval
- ANDA ANDA091240
- On the market since
- May 19, 2016
- Package NDCs
53002-3501-253002-3501-3- Official label
- DailyMed (National Library of Medicine), updated Jan 31, 2023
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