Class III · Low risk Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141…
Reason Cross contamination with other products
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by…
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, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India…
Reason Cross contamination with other products
Class II · Moderate risk Terminated
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for…
Reason Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this…
Class II · Moderate risk Terminated
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia…
Reason Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this…
Class II · Moderate risk Terminated
MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy…
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.