January 2018 FDA Recall Mycamine by Astellas Pharma Us Inc
D-0548-2018 - Labeling
This Class II drug recall was voluntarily initiated by Astellas Pharma Us Inc on January 22, 2018 for the product Mycamine. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0548-2018
Labeling: Label Error on Declared Strength
01-22-2018
02-14-2018
63600 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Astellas Pharma US Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-01-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
