FDA Drug recall D-0757-2021
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmace…
- FDA Drug
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmace… by Xellia Pharmaceuticals Usa, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0757-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-06 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Xellia Pharmaceuticals Usa |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Lot 467111, exp 1/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0757-2021%22
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