Recalls / Class I
Class ID-0268-2025
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., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
- 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. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
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
- unknown
- 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-0268-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.