ICU Medical has issued a voluntary recall of Potassium Chloride Injection 20 mEq, packaged in 100 mL bags, due to incorrect overwrap labels stating 10 mEq instead of 20 mEq. The recall focuses on lot number 1023172 (NDC 0990-7074-26) with an expiration date of January 31, 2026.
This mislabeling issue was identified during internal review, and the company has halted distribution of the affected product.
The recall applies to shipments provided to healthcare facilities across the United States. The total number of affected units has not been disclosed. ICU Medical is coordinating with regulatory agencies, removing the mislabeled items from circulation, and advising purchasers on returns and refunds.
What to look for?
Product name and description:
- Potassium Chloride Injection 20 mEq, 100 mL bags
- Overwrap labels incorrectly showing Potassium Chloride Injection 10 mEq
- Packaged in cases labeled:
- “NDC 0990-7075-26, CASE PACK 1×24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO.1023172, EXP. DATE 2026-01”
Identifiers:
- Lot number: 1023172 (NDC 0990-7074-26)
- Expiration date: January 31, 2026
- This information is on the overwrap and box labeling
Affected purchase locations and dates:
- Distributed nationwide to hospitals, clinics, and other medical facilities
- Shipped between January 2023 and August 2023
What should buyers do?
Handling the recalled product:
- Do not use the affected bags
- Return them to the place of purchase or the distributor
Refunds, replacements, or repairs:
- Contact ICU Medical Customer Support at (844) 654-7780 for return instructions and refund or replacement details
- Assistance is available Monday–Friday, 9 AM–5 PM EST
Health and safety advice:
- Mislabeling may lead to an overdose of potassium, causing possible hyperkalemia
- Symptoms can include muscle weakness, vertigo, confusion, and irregular heartbeat
- Seek immediate medical help if any adverse health effects occur