Recalls / Class I
Class ID-0267-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Intravenous
- NDCs
- 0990-7074, 0990-7075, 0990-7077
- FDA application
- NDA020161
- Affected lot / code info
- Lot 1023172, Exp Date: 31 January 2026
Why it was recalled
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.
Recalling firm
- Firm
- ICU Medical, Inc.
- Manufacturer
- ICU Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 67,488 flexible containers
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-02-13
- FDA classified
- 2025-03-10
- Posted by FDA
- 2025-03-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0267-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.