Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns
Baxter Healthcare is recalling 54,528 bags of 5% Dextrose Injection because the bags may leak, compromising 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical products, are rated as Severe (4).
Plain-English summary
Baxter Healthcare Corporation is recalling 54,528 bags of 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container. The product is identified by Lot P361618 and has an expiration date of 09/30/18.
The recall was initiated because the bags have the potential to leak, which creates a lack of assurance of sterility. This defect poses a risk to patients who receive the intravenous solution.
The affected product was distributed nationwide, in Puerto Rico, and in Saudi Arabia. Healthcare providers and patients should stop using the recalled product and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — IV Solution
- Affected units
- 54,528
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: P361618
- Exp 09/30/18
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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