Drug & medication recalls Moderate risk

Astellas Pharma US Inc recalls Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbro…

Recall date
January 22, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0548-2018
FDA classification
Class II
Brand / firm
Astellas Pharma US Inc
Sold / distributed
Nationwide.

Why it was recalled

Labeling: Label Error on Declared Strength

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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