Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Distributed by / for | Fresenius Kabi Compounding, LLC |
| NDC | 71506-079-56 |
| Full product label | 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. |
| Recalling firm | Fresenius Kabi Compounding, LLC |
| Distribution | US Nationwide. |
| Quantity | 10,548 bags |
| Recall initiated | 2026-02-05 |
| Report date | 2026-02-18 |
| Recall completed | — |
| Recall number | D-0335-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Canton MA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗