Why it was recalled
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Product description
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
Lot numbers, UPCs & expiration codes
Lot 467111, exp 1/2023
Where it was sold
Nationwide USA
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-0757-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 6, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 9,161 (50mg and 100 mg vials total)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- XELLIA PHARMACEUTICALS USA, LLC
Original FDA data
Every field from FDA enforcement report D-0757-2021, exactly as published.
Show all FDA fields
- City
- Buffalo Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88457
- Address
- 2150 E Lake Cook Rd
- Code information
- Lot 467111, exp 1/2023
- Postal code
- 60089-1862
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0757-2021
- Classification
- Class II
- Recalling firm
- XELLIA PHARMACEUTICALS USA, LLC
- Product quantity
- 9,161 (50mg and 100 mg vials total)
- Termination date
- Sep 29, 2024
- Reason for recall
- Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 6, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021