D-0268-2025 Class I Ongoing
FDA drug recall D-0268-2025 was initiated by ICU Medical, Inc. on February 13, 2025 and is designated Class I. 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 The recall status is ongoing. Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2025
- Initiation Date
- February 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
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
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot 1023172, Exp Date: 31 January 2026