D-0334-2026 Class II Ongoing
FDA drug recall D-0334-2026 was initiated by Fresenius Kabi Compounding, LLC on February 5, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 1410 bags.
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