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

Recall Number: D-0548-2018

Firm: Astellas Pharma US Inc

Classification: Class II

Status: Terminated

Report Date: 20180214

Initiation Date: 20180122

Termination Date: 20190501

Reason for Recall

Labeling: Label Error on Declared Strength

Product Description

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