PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 14, 2018 Initiated: January 22, 2018 #D-0548-2018

Product Description

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

Details

Recalling Firm
Astellas Pharma US Inc
Units Affected
63600 vials
Distribution
Nationwide.
Location
Northbrook, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Astellas Pharma US Inc. Units affected: 63600 vials.
Why was this product recalled?
Labeling: Label Error on Declared Strength
Which agency issued this recall?
This recall was issued by the FDA Drug on February 14, 2018. Severity: Moderate. Recall number: D-0548-2018.