FDA recall D-0019-2025

Fresenius Kabi Compounding, LLC · Class II · drug

Product

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

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-0019-2025