NDC 42543-406
Potassium Citrateextended Release 5 meq tablet
On the label: Vensun Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Strides Pharma Science Limited | Puducherry, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 24, 2023 · 2 inspections, 1 with FDA action |
Recalls
- Jul 18, 2018 · Class II · Vensun Pharmaceuticals Inc
Failed Tablet/Capsule Specifications: Tablet breakage
Lots: Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019. - Jul 18, 2018 · Class II · Vensun Pharmaceuticals Inc
Failed Tablet/Capsule Specifications: Tablet breakage
Lots: Lot #: 9570012, Exp. June-2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Anhydrous Citric Acid: every company that makes it
- Form
- tablet, oral
- Strength
- 5 meq
- Approval
- ANDA ANDA206813
- On the market since
- Nov 1, 2017
- Package NDCs
42543-406-01- Official label
- DailyMed (National Library of Medicine), updated Jul 1, 2025
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