FDA DrugsClass II
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride In...
Published: February 18, 2026Recall ID: D-0334-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Canton |
| State | MA |
| Event id | 98391 |
| Address 1 | 20 Dan Rd |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 02021-2809 |
| Report date | 20260218 |
| Product type | Drugs |
| Product quantity | 1410 bags |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260205 |
| Initial firm notification | Letter |
| Center classification date | 20260213 |
Overview
- Recalling FirmFresenius Kabi Compounding, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.