FDAClass IIIApril 4, 2018

Flucanazole Injection recall: Superpotent

Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc.…

Why was Flucanazole Injection recalled?

Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

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 A060644, May 2018

Product
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc.…
Recalling firm
Renaissance Lakewood, LLC
Quantity
1277 bags
Distribution
Nationwide
Recall date
April 4, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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