FDA-Drug2018-02-14Class II

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

Astellas Pharma US Inc
Hazard

Labeling: Label Error on Declared Strength

Sold states
Nationwide.
Affected count
63600 vials
Manufactured in
1 Astellas Way, N/A, Northbrook, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0548-2018

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