D-0334-2026 Class II Ongoing

Recalled by Fresenius Kabi Compounding, LLC — Canton, MA

Recall Details

Product Type
Drugs
Report Date
February 18, 2026
Initiation Date
February 5, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1410 bags

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide.

Code Information

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