Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns
Hospira Inc. is recalling 128,050 units of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises 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, and the hazard involves a lack of sterility assurance for an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
Hospira Inc. is recalling 128,050 ADD-Vantage flexible containers of 0.9% Sodium Chloride Injection, USP, 100 mL. The product is a prescription-only intravenous solution manufactured in Lake Forest, Illinois. The recall involves Lot# 44-110-JT with an expiration date of 08/16.
The recall was initiated because the product has the potential to leak at the administrative port. This defect creates a lack of sterility assurance, meaning the solution may not be sterile as required for intravenous administration.
The affected product was distributed nationwide. Healthcare providers and facilities should stop using the recalled lot and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 128,050
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# 44-110-JT
- Exp 08/16
Distribution
Distributed nationwide across the United States.
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