ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Recall Number: D-0334-2026

Firm: Fresenius Kabi Compounding, LLC

Classification: Class II

Status: Ongoing

Report Date: 20260218

Initiation Date: 20260205

Termination Date:

Lack of Assurance of Sterility

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56