CLASS II Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalled
Astellas Pharma US is recalling Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 22 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0548-2018
- FDA event ID
- 78981
- Recalling firm
- Astellas Pharma US, Northbrook, IL
- Brand
- Mycamine
- Manufacturer
- Astellas Pharma US, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jan 2018
- FDA classified
- 27 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Jan 2018 | Recall initiated by company | |
| 14 Feb 2018 | Published in enforcement report | +23 days |
| 27 Feb 2018 | Classified by FDA | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength
Product as listed by the FDA
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
Where it was distributed
Nationwide.
Questions about this recall
Is Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalled?
Yes. Astellas Pharma US recalled Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial on 22 Jan 2018. The recall is Class II and its status is Terminated. Recall number D-0548-2018.
Why was it recalled?
Labeling: Label Error on Declared Strength
Which lots are affected?
Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Astellas Pharma US
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|---|---|---|---|---|---|
| Drug | CLASS I | Astagraf XL (tacrolimus extended-release capsules) 5 mg recalledAstagraf Xl | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS I | Prograf (tacrolimus) capsules, USP, 5 mg recalled by Astellas Pharma USPrograf | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS II | Tarceva (erlotinib) Tablets, 150 mg recalled by Astellas Pharma US | Astellas Pharma US | Potency & Assay | Nationwide |
| Drug | CLASS II | AmBisome (amphotericin B) liposome for injection, 50mg vial recalled | Astellas Pharma US | Sterility | Nationwide |
Other Micafungin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial recalled | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS III | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial recalled | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile recalled | Xellia Pharmaceuticals Usa | Sterility | Nationwide |
| Drug | CLASS II | Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile recalled | Xellia Pharmaceuticals Usa | Sterility | Nationwide |