Status
Ongoing
Drug Enforcement D-0267-2025
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.
Classification
Class I
Report Date
March 19, 2025
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 67,488 flexible containers
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- ICU Medical, Inc.
- Address
-
600 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0267-2025
- Event ID
- 96250
- Recall initiation date
- February 13, 2025
- Center classification date
- March 10, 2025
- Code info
- Lot 1023172, Exp Date: 31 January 2026
- More code info
- —