Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Hospira Inc. is recalling 325,056 bags of 0.9% Sodium Chloride Injection USP, 100 mL, due to a potential lack of assurance of 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 severity score under the rubric for significant injury or property damage reports or high-risk defects.
Plain-English summary
Hospira Inc. is recalling 325,056 bags of 0.9% Sodium Chloride Injection USP, 100 mL (NDC 0409-7984-23). The affected product is identified by Lot Number 02-117-JT with an expiration date of 02/13. The recall is being conducted nationwide.
The recall is due to a lack of assurance of sterility. There is a potential for the solution to leak from the administrative port to the fill tube seal. This defect could compromise the sterility of the injection.
Healthcare providers and facilities should stop using the affected product and contact Hospira Inc. for further instructions. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 325,056
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 (1)
- Lot Number 02-117-JT Exp. 02/13
Distribution
Distributed nationwide across the United States.
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