NDC 0338-0703
Potassium Chloride 29.8 g per 1000 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Jayuya, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 19, 2024 · 15 inspections, 5 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
| Baxter Healthcare Corporation | Aibonito, PR, United States | Tests it | Problems found, fixed voluntarilySep 23, 2026 · 4 inspections |
Recalls
- Nov 10, 2014 · Class II · Baxter Healthcare Corp.
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Lots: Lot #: P319160, Exp 06/30/15 - Sep 8, 2014 · Class II · Baxter Healthcare Corp
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Lots: Lot P318220, EXP 05/31/15 - Jul 11, 2014 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Lots: Lot #: P309476, Exp 10/14
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
- injection, solution, intravenous
- Strength
- 29.8 g per 1000 mL
- Approval
- NDA NDA019904
- On the market since
- Dec 26, 1989
- Package NDCs
0338-0703-410338-0703-48- Official label
- DailyMed (National Library of Medicine), updated Jun 13, 2024
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