Potassium Chloride Injection Recalled: Overwrap Labeling Shows Incorrect Strength
ICU Medical recalls Potassium Chloride 20 mEq IV injection due to mislabeled overwrap showing 10 mEq instead of the correct strength. The correct dose is printed on the actual container.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies to this recall, establishing a minimum severity of Severe. The mislabeling of an intravenous medication's strength creates risk for dosing errors in clinical use.
Plain-English summary
ICU Medical is recalling Potassium Chloride Intravenous Injection, 20 mEq in 100 mL flexible containers. The affected lot is 1023172, expiring January 31, 2026, and the product was distributed nationwide in the USA. Approximately 67,488 flexible containers are involved in the recall.
The issue is a labeling error: cases labeled Potassium Chloride 20 mEq may contain flexible containers with overwrap mislabeled as 10 mEq. However, the correct dosage strength of 20 mEq is printed on the labeling attached to the product's flexible container. The mislabeling on the external overwrap creates potential for medication errors.
Healthcare providers and patients should use the dosage strength shown on the flexible container's attached label, not the overwrap label. Containers from lot 1023172 should be carefully verified before use to confirm correct strength labeling on the container itself.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- ICU Medical, Inc.
- Category
- Drug — Intravenous electrolyte
- Hazard
- mis-labeling
- dosing-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1023172
- Exp Date: 31 January 2026
Distribution
Distributed nationwide across the United States.
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