Injectable Sodium Chloride Solution Recalled Due to Sterility Assurance Concerns
Otsuka ICU Medical is recalling 509,360 units of sodium chloride 0.9% injection bags nationwide due to potential flexible container leaks that could compromise sterility. The recall affects lot 1029921 (expiration February 28, 2027).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is classified as High because it involves a potential contamination hazard in an injectable medication with direct bloodstream access, meeting the rubric criterion for risk-of-harm products. No illnesses or injuries have been reported in the source material, and the sterility and container integrity concerns are preventive rather than confirmed.
Plain-English summary
Otsuka ICU Medical LLC is recalling 509,360 units of Sodium Chloride (0.9%) Injection, USP, 100 mL bags nationwide. The recalled product is distributed throughout the USA under NDC 0990-7984-37 and lot number 1029921 with an expiration date of February 28, 2027.
The recall has been issued due to a lack of assurance of sterility and the potential for flexible container leaks. These leaks could compromise the sterile environment of the injectable solution and allow bacterial or other microbial contamination.
Sodium chloride injection is administered intravenously in medical and hospital settings. Contaminated solutions could pose a serious risk to patients receiving the compromised medication directly into the bloodstream.
Healthcare facilities and providers should identify and quarantine affected units of lot 1029921. Any patients or healthcare providers who have concerns about adverse events related to this product should report them to Otsuka ICU Medical LLC or the FDA.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Category
- Drug — Injectable / IV Solution
- Hazard
- sterility-assurance
- container-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1029921
- Exp Date: 28 February 2027
Distribution
Distributed nationwide across the United States.
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