Drug 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
D-0548-2018
Product summary
- Event
- Event 78981
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63600 vials
- Official record key
drug-enforcement:D-0548-2018
Official wording
Reason: Labeling: Label Error on Declared Strength
Code information: Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error