NDC 68001-396
Potassium Chloride 750 mg capsule, extended release
On the label: BluePoint Laboratories..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Jun 25, 2024 · Class I · Amerisource Health Services LLC
Failed Dissolution Specifications
Lots: [100 count bottles]: Lot 17221738, Exp 07/31/2024; Lot 17222494, Exp 10/31/2024; Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025; [500 count bottles]: Lot 17221823, Lot 17221830, Exp 07/31/2024; Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2…
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
- capsule, extended release, oral
- Strength
- 750 mg
- Approval
- ANDA ANDA202868
- On the market since
- Jul 3, 2019
- Package NDCs
68001-396-0068001-396-03- Official label
- DailyMed (National Library of Medicine), updated Jul 3, 2019
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