FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
What this means
Baxter Healthcare Corporation is recalling one lot of Vancomycin Injection (NDC 0338-3583-01, Lot #NC193894) due to deviations from good manufacturing practices (CGMP). The affected lot was distributed nationwide in the US, Puerto Rico, and Chile.
- If you have this medication in your facility or pharmacy, check the lot number (NC193894) and expiration date (04/25/2027).
- Contact your pharmacy or healthcare provider if you have questions about whether you received this lot.
- Do not use this lot; return it to your supplier or pharmacy for proper disposal.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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