NDC 53002-1246
Triamterene and Hydrochlorothiazide 25 mg / 37.5 mg capsule
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Lannett Company, Inc.'s NDC 0527-1632.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lannett Company, LLC | Seymour, IN, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilyOct 21, 2022 · 9 inspections, 1 with FDA action |
| Lannett Company, Inc. | Location not on file | Tests it | Not inspected on record |
| Legacy Pharmaceutical Packaging | Location not on file | Packages it | Not inspected on record |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Nov 9, 2022 · Class III · Lannett Company Inc.
Failed Impurity/Degradation Specifications
Lots: Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023) - Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots: Batch 21000279A, 21000280A
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydrochlorothiazide and Triamterene: every company that makes it
- Form
- capsule
- Strength
- 25 mg / 37.5 mg
- Approval
- ANDA ANDA201407
- On the market since
- Dec 9, 2011
- Package NDCs
53002-1246-053002-1246-3- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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