FDAClass IIDecember 28, 2016

Fluconazole Injection recall: Sterility Concern

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL…

Why was Fluconazole Injection recalled?

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

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 #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017

Product
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL…
Recalling firm
Baxter Healthcare Corporation
Quantity
30,910 bags
Distribution
United States, United Arab Emirates, and Colombia
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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