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

FDA recall notice · announced February 14, 2018 · Astellas Pharma Us

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Labeling: Label Error on Declared Strength

Notes

Distribution: Nationwide.
Lot/code information: Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
Quantity: 63600 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.