FDA recall D-0548-2018

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

Reason for recall

Labeling: Label Error on Declared Strength

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2018-01-22

Report date

2018-02-14

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

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