D-0143-2026 Class II Ongoing
FDA drug recall D-0143-2026 was initiated by Otsuka ICU Medical LLC on October 27, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential for flexible container leaks. The recall status is ongoing. Affected quantity: 509,360 100 mL bags.
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2025
- Initiation Date
- October 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 509,360 100 mL bags
Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Distribution Pattern
Distributed Nationwide in the USA.
Code Information
Lot # 1029921, Exp Date: 28 February 2027