Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
0.9% SODIUM CHLORIDE Injection Recalled by Otsuka ICU Medical LLC Due to Lack of Assurance of Sterility: Potential for flexible...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Otsuka ICU Medical LLC directly.
Affected Products
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Quantity: 509,360 100 mL bags
Why Was This Recalled?
Lack of Assurance of Sterility: Potential for flexible container leaks.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Otsuka ICU Medical LLC
Otsuka ICU Medical LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report