FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter Clindamycin Injection recalled for CGMP manufacturing deviations
What this means
Baxter Healthcare Corporation is recalling specific lots of Clindamycin Injection USP in 5% Dextrose due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lots are NC193764 (expiration 10/18/2027) and NC195232 (expiration 11/25/2027), distributed nationwide in the US, Puerto Rico, and Chile.
- Check your pharmacy or hospital records for Clindamycin Injection with lot numbers NC193764 or NC195232.
- Do not use affected lots; contact your pharmacy or healthcare provider for guidance on safe alternatives.
- Report any adverse effects to FDA MedWatch at 1-888-SAFEMED or online at fda.gov/medwatch.
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
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0808-2026More 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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