Class III · Low risk Completed
Micafungin for injection
Reason Cross contamination with other products
Mycamine
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Error on Declared Strength
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
- Recalling firm
- Astellas Pharma US Inc
- NDC code
- 0469-3211-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0548-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Micafungin recalls
See all
Class III · Low risk Completed
Micafungin for injection
Reason Cross contamination with other products
Class II · Moderate risk Terminated
Micafungin for Injection
Reason Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk Terminated
Micafungin for Injection
Reason Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk Terminated
Mycamine
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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