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

FDA recall notice · announced April 5, 2023 · Apollo Care

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: MO
Lot/code information: Lot #: AC-016581
Quantity: 215 bags
Status: Ongoing
Products in this recall event:
- 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 (D-0487-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.