FDA DrugsClass II
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, US...
Published: February 18, 2026Recall ID: D-0335-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Additional Source Details
| Field | Value |
|---|---|
| City | Canton |
| State | MA |
| Event id | 98391 |
| Address 1 | 20 Dan Rd |
| Address 2 | N/A |
| Code info | Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C274-000049413, Exp Date: 5-May-26; Lot # C274-000049571, Exp Date: 10-May-26; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26. |
| Postal code | 02021-2809 |
| Report date | 20260218 |
| Product type | Drugs |
| Product quantity | 10,548 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.