FDA Drug recall D-0548-2018
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc by Astellas Pharma Us, citing labeling: Label Error on Declared Strength.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0548-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-22 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Astellas Pharma Us |
| Distribution | US |
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
Labeling: Label Error on Declared Strength
Identifiers
| ndc | 0469-3250-10 |
|---|---|
| ndc | 0469-3211-10 |
| code_info | Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0548-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.