Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Recalled by Astellas Pharma US Inc Due to Labeling: Label Error on Declared Strength

Date: January 22, 2018
Company: Astellas Pharma US Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Astellas Pharma US Inc directly.

Affected Products

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

Quantity: 63600 vials

Why Was This Recalled?

Labeling: Label Error on Declared Strength

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Astellas Pharma US Inc

Astellas Pharma US Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report