PlainRecalls
FDA Drug Moderate Class II Ongoing

fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

Reported: April 10, 2024 Initiated: March 22, 2024 #D-0432-2024

Product Description

fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

Reason for Recall

Lack of Assurance of Sterility: leaking bags

Details

Units Affected
187 cassettes
Distribution
Nationwide within the U.S
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1. Recalled by IntegraDose Compounding Services LLC. Units affected: 187 cassettes.
Why was this product recalled?
Lack of Assurance of Sterility: leaking bags
Which agency issued this recall?
This recall was issued by the FDA Drug on April 10, 2024. Severity: Moderate. Recall number: D-0432-2024.