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.
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
Lot numbers, UPCs & expiration codes
Lot 1023172, Exp Date: 31 January 2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0267-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Feb 13, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 67,488 flexible containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical, Inc.
Original FDA data
Every field from FDA enforcement report D-0267-2025, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 96250
- Address
- 600 N Field Dr
- Code information
- Lot 1023172, Exp Date: 31 January 2026
- Postal code
- 60045-4835
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0267-2025
- Classification
- Class I
- Recalling firm
- ICU Medical, Inc.
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 13, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 10, 2025