Baxter Healthcare Corporation — Class II: Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL
Baxter Healthcare Corporation has initiated a Class II recall for Vasopressin in 0.9% Sodium Chloride Injection (20 units per 100 mL) due to Current Good Manufacturing Practice (CGMP) deviations. The recall is currently listed as ongoing and affects product NDC 0338-9640-12.
This affects Baxter Healthcare Corporation, specifically their manufacturing and quality units involved with sterile injectable products, as well as healthcare facilities and distributors utilizing this specific Vasopressin concentration.
A Class II recall due to CGMP deviations suggests that while the health hazard may not be immediate or severe, there were significant failures in the manufacturing process that could compromise product quality or consistency. The source does not specify the exact nature of the deviation, but for sterile injectables, this typically triggers heightened regulatory scrutiny of the facility's quality management system and production controls.
QA and Manufacturing teams should verify if any lots of this NDC are in current inventory and review internal CGMP controls. Regulatory teams should monitor for follow-up details regarding the specific nature of the deviations to determine if broader systemic corrections are required.
Class II. Reason: CGMP Deviations. Product: Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.. Firm: Baxter Healthcare Corporation (Deerfield IL United States). Status: Ongoing.
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