Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
Baxter Healthcare is recalling 606 bags of Dextrose Injection, USP, 70% due to the presence of stainless steel particles in the solution.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 606 bags of Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06). The recall is due to the presence of particulate matter, specifically identified as stainless steel particles, in the solution.
The affected product is Lot #Y495066 with an expiration date of July 31, 2027. The product was distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injectable Solution
- Affected units
- 606
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 #: Y495066
- Exp. Date July 31
- 2027
Distribution
Distributed nationwide across the United States.
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