PlainRecalls
FDA Drug Moderate Class II Terminated

ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

Reported: October 6, 2021 Initiated: September 17, 2021 #D-0896-2021

Product Description

ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

Reason for Recall

Lack of sterility assurance.

Details

Units Affected
2,614 syringes
Distribution
NH, MA, MN
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1. Recalled by IntegraDose Compounding Services LLC. Units affected: 2,614 syringes.
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-0896-2021.