FDAClass IIFebruary 14, 2018

Mycamine recall: Labeling Error

Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10

Why was Mycamine recalled?

Labeling: Label Error on Declared Strength

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?

Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20

Product
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10
Recalling firm
Astellas Pharma US Inc
Quantity
63600 vials
Distribution
Nationwide.
Recall date
February 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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