FDAClass IIOctober 6, 2021

ceFAZolin recall: Sterility Concern

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

Why was ceFAZolin recalled?

Lack of sterility assurance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021

Product
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN.…
Recalling firm
IntegraDose Compounding Services LLC
Quantity
2,614 syringes
Distribution
NH, MA, MN
Recall date
October 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls