Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns
Baxter Healthcare is recalling 139,680 containers of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for bags to leak.
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: The recall involves a risk-of-harm product (sterility failure in an IV drug) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 139,680 containers of 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container. The affected product is identified by NDC 0338-0049-38 and includes Lot #s P389684 and P389742, with an expiration date of 8/31/2020.
The recall was initiated because the bags have the potential to leak, resulting in a lack of assurance of sterility. This product is a prescription-only intravenous medication manufactured by Baxter Healthcare Corporation in Deerfield, IL.
The affected units were distributed nationwide in the United States and Puerto Rico. Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — IV Solution
- Affected units
- 139,680
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 (3)
- Lot #s: P389684
- P389742
- Exp. 8/31/2020
Distribution
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