NDC 0990-7077

Potassium Chloride 400 meq per 1000 mL injection, solution

Where it's made

Factory	Where	Role	Last FDA inspection
Otsuka ICU Medical LLC	Austin, TX, United States	Makes it, tests it, packages it and labels it	Problems found, fixed voluntarilyMar 10, 2017 · 5 inspections, 1 with FDA action

Oct 29, 2025 · Class I · Otsuka ICU Medical LLC
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Lots: Lot # 1030613, Exp Date: 09/30/2026
Oct 29, 2025 · Class I · Otsuka ICU Medical LLC
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Lots: Lot # 1030613, Exp Date: 09/30/2026
Feb 13, 2025 · Class I · ICU Medical, Inc.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Lots: Lot 1023172, Exp Date: 31 January 2026
Feb 13, 2025 · Class I · ICU Medical, Inc.
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Lots: Lot 1023172, Exp Date: 31 January 2026

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Potassium Cation: every company that makes it
Form: injection, solution, intravenous
Strength: 400 meq per 1000 mL
Approval: NDA NDA020161
On the market since: Apr 1, 2019
Package NDCs: 0990-7077-14 0990-7077-26
Official label: DailyMed (National Library of Medicine), updated Oct 29, 2025

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