Class II recall: Baxter Healthcare Corporation: Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Sin

The FDA has classified as a Class II recall a batch of Baxter Healthcare Corporation's Vancomycin Injection, USP in 5% Dextrose (1 g per 200 mL, 5 mg/mL), supplied in GALAXY Single-Dose Containers under NDC 0338-3552-48. The recall notice cites current good manufacturing practice (CGMP) deviations as the reason for the action. No further clinical details, such as specific defect mechanisms or affected lot numbers, were included in the source text.

Most relevant for: Patients receiving intravenous vancomycin therapy from the affected Baxter Healthcare batch, particularly hospitalized patients requiring antibiotic treatment for serious infections.

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