Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Hospira is recalling 314,600 bags of 0.9% Sodium Chloride Injection USP due to potential channel leaks that may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for drug recalls involving potential sterility issues.
Plain-English summary
Hospira Inc. is recalling 314,600 bags of 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, NDC 00409-7101-68. The recall affects lots 49-084-JT and 49-119-JT, which were distributed in the United States.
The recall was initiated due to a lack of assurance of sterility. The source text identifies potential channel leaks near the threaded vial port as the cause of this defect.
Healthcare providers and patients should stop using the affected product and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluid
- Hazard
- Affected units
- 314,600
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 #: 49-084-JT
- 49-119-JT
Distribution
Distribution scope not specified by the agency.
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