Reported Feb 14, 2018 · Terminated

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

Astellas Pharma US Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Astellas Pharma US Inc · 1 Astellas Way · Northbrook, IL · 60062-6111

Is this the product you have?

  • Mycamine (micafungin) for Injection 100 mg/vial
  • Single-Dose Vial Rx only Marketed byAstellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10
Lot codes and dates
  • Lots
    • F1700164 Exp. 02/20
    • A000000220 Exp. 06/20
Amount recalled
63600 vials

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 1, 2019 · Data as of Sep 19, 7:18 PM UTC

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