Product: Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason for recall: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Recall initiated: 20230208
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated