PlainRecalls
FDA Drug Moderate Class II Ongoing

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

Reported: May 14, 2025 Initiated: April 15, 2025 #D-0409-2025

Product Description

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Apollo Care, LLC
Units Affected
440 bags
Distribution
MO
Location
Columbia, MO

Frequently Asked Questions

What product was recalled?
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25. Recalled by Apollo Care, LLC. Units affected: 440 bags.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on May 14, 2025. Severity: Moderate. Recall number: D-0409-2025.