PlainRecalls
FDA Drug Moderate Class II Ongoing

FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25

Reported: May 24, 2023 Initiated: May 2, 2023 #D-0646-2023

Product Description

FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Apollo Care, LLC
Units Affected
308 bags
Distribution
Missouri only
Location
Columbia, MO

Frequently Asked Questions

What product was recalled?
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25. Recalled by Apollo Care, LLC. Units affected: 308 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 24, 2023. Severity: Moderate. Recall number: D-0646-2023.