Why it was recalled
Labeling: Label Error on Declared Strength
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
Lot numbers, UPCs & expiration codes
Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0548-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 22, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- 63600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Astellas Pharma US Inc
Original FDA data
Every field from FDA enforcement report D-0548-2018, exactly as published.
Show all FDA fields
- City
- Northbrook
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78981
- Address
- 1 Astellas Way
- Code information
- Lots: F1700164 Exp. 02/20; A000000220 Exp. 06/20
- Postal code
- 60062-6111
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0548-2018
- Classification
- Class II
- Recalling firm
- Astellas Pharma US Inc
- Product quantity
- 63600 vials
- Termination date
- May 1, 2019
- Reason for recall
- Labeling: Label Error on Declared Strength
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 22, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2018