D-0487-2023 Class II Ongoing

Recalled by Apollo Care — Columbia, MO

Recall Details

Product Type
Drugs
Report Date
April 5, 2023
Initiation Date
February 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
215 bags

Product Description

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.

Distribution Pattern

MO

Code Information

Lot #: AC-016581