D-0548-2018 Class II Terminated
FDA drug recall D-0548-2018 was initiated by Astellas Pharma US Inc on January 22, 2018 and is designated Class II. Reason for recall: Labeling: Label Error on Declared Strength The recall status is terminated (terminated May 1, 2019). Affected quantity: 63600 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- January 22, 2018
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63600 vials
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
Distribution Pattern
Nationwide.
Code Information
Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20