PlainRecalls
FDA Drug Moderate Class II Terminated

ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

Reported: October 6, 2021 Initiated: September 17, 2021 #D-0897-2021

Product Description

ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

Reason for Recall

Lack of sterility assurance.

Details

Units Affected
589 bags
Distribution
NH, MA, MN
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1. Recalled by IntegraDose Compounding Services LLC. Units affected: 589 bags.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 6, 2021. Severity: Moderate. Recall number: D-0897-2021.