Mycamine Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0469-3250
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mycamine (NDC 0469-3250). A significant event, classified as Class II, was initiated on Jan 22, 2018 by Astellas Pharma Us, Inc.. The reported reason for this action was: "Labeling: Label Error on Declared Strength"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label Error on Declared Strength
Jan 22, 2018
Feb 14, 2018
63600 vials
Recall Profile & Regulatory Data
Event ID
78981
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Astellas Pharma US Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
May 01, 2019
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
Batch or Lot Expiration Information
Lot# Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
Affected Packages Involved in this Recall
0469-3250-10Product
0469-3211-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
