0.9% SODIUM CHLORIDE Injection recall: Sterility Concern
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Why was 0.9% SODIUM CHLORIDE Injection recalled?
Lack of Assurance of Sterility: Potential for flexible container leaks.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 1029921, Exp Date: 28 February 2027
- Product
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Recalling firm
- Otsuka ICU Medical LLC
- Quantity
- 509,360 100 mL bags
- Distribution
- Distributed Nationwide in the USA.
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)