Baxter Healthcare Corporation — Class I: Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfi
Baxter Healthcare Corporation has initiated a Class I recall of Dextrose Injection, USP, 70% in 2000 mL bags due to the presence of particulate matter identified as stainless steel particles. The recall is currently classified as ongoing by the FDA.
This affects Baxter Healthcare Corporation, healthcare providers utilizing large-volume dextrose injections, and hospital pharmacy departments responsible for sterile compounding or fluid administration.
A Class I designation is the most serious recall category, indicating that exposure to the product could cause serious adverse health consequences or death. The presence of metallic particulate matter in an injectable solution suggests a significant failure in the manufacturing or filtration process, potentially involving equipment degradation or mechanical failure. Regulatory teams may expect increased scrutiny regarding equipment maintenance and batch release protocols at the affected facility.
Impacted facilities should immediately identify and sequester affected NDC 00338-0719-06 stock. QA teams should review supplier quality and maintenance logs for stainless steel equipment to identify potential failure points in the manufacturing line. Clinical staff must monitor for adverse events related to particulate injection.
Class I. Reason: Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.. Product: Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06. Firm: Baxter Healthcare Corporation (Deerfield IL United States). Status: Ongoing.
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