FDA recall D-0018-2025
Fresenius Kabi Compounding, LLC · Class II · drug
Product
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Reason for recall
cGMP violations
Distribution
Product was distributed to 125 direct accounts nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2024-09-25
- Report date
- 2024-10-30
- Termination date
- 2025-08-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Canton, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2025