Status
Ongoing
Drug Enforcement D-0268-2025
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Classification
Class I
Report Date
March 19, 2025
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- unknown
- Reason for recall
- Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
- 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-0268-2025
- 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
- —