Recalls / Class II
Class IID-0548-2018
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
- Brand name
- Mycamine
- Generic name
- Micafungin Sodium
- Active ingredient
- Micafungin Sodium
- Route
- Intravenous
- NDCs
- 0469-3250, 0469-3211
- FDA application
- NDA021506
- Affected lot / code info
- Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
Why it was recalled
Labeling: Label Error on Declared Strength
Recalling firm
- Firm
- Astellas Pharma US Inc
- Manufacturer
- Astellas Pharma US, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Astellas Way, N/A, Northbrook, Illinois 60062-6111
Distribution
- Quantity
- 63600 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-01-22
- FDA classified
- 2018-02-27
- Posted by FDA
- 2018-02-14
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0548-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.