Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns
Baxter Healthcare is recalling 157,080 containers of 0.9% Sodium Chloride Injection due to complaints of mold in the overpouch, raising concerns about sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of infection or serious injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 157,080 containers of 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container (NDC 0338-0049-03). The recall is being conducted due to a lack of assurance of sterility, specifically following complaints of mold in the overpouch.
The affected product is identified by Lot #C926642 and Product Code 2B1323N. The product was distributed nationwide. This is an intravenous prescription drug used for medical purposes.
Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 157,080
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 #C926642
- Product Code: 2B1323N
Distribution
Distributed nationwide across the United States.
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