D-0181-2026 Class I Ongoing
FDA drug recall D-0181-2026 was initiated by Otsuka ICU Medical LLC on October 29, 2025 and is designated Class I. Reason for recall: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2025
- Initiation Date
- October 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
Reason for Recall
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Distribution Pattern
US Nationwide.
Code Information
Lot # 1030613, Exp Date: 09/30/2026