FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Co...

  • U.S. Food and Drug Administration
  • September 9, 2026
  • ID: D-0820-2026

Drug Enforcement Report Details

Recall NumberD-0820-2026
Recalling FirmBaxter Healthcare Corporation
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternUS Nationwide; Puerto Rico; and Chile.
StatusOngoing
Product Description

Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.

Reason for Recall

CGMP Deviations

Code Information

Lot # NC193894, Exp Date: 04/25/2027.


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