NDC 53002-2034
Potassium Chloride 750 mg tablet, extended release
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Strides Pharma Science Limited's NDC 64380-861.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Strides Pharma Science Limited | Bengaluru, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 20, 2026 · 11 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Sep 27, 2021 · Class II · Strides Pharma Inc.
Failed Dissolution Specifications
Lots: Lot 7240840A, exp. 12/31/2021 - Aug 24, 2020 · Class II · Strides Inc.
Failed Dissolution Specifications
Lots: 7240675A; Exp. 12/31/2021 - Feb 17, 2020 · Class III · Strides Pharma Science Limited
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Lots: Lot #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Potassium Cation: every company that makes it
- Form
- tablet, extended release
- Strength
- 750 mg
- Approval
- ANDA ANDA210733
- On the market since
- Nov 27, 2018
- Package NDCs
53002-2034-053002-2034-3- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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