FDA-Drug2026-02-18Class II

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

Fresenius Kabi Compounding, LLC
Hazard
Lack of Assurance of Sterility
Sold states
US Nationwide.
Affected count
1410 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2026

Original summary

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 Lack of Assurance of Sterility Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26 Distribution: US Nationwide. Affected quantity: 1410 bags

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