Xellia Pharmaceuticals USA, LLC FDA Recalls

2 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured foClass IIAug 6, 2021Labeling; Incorrect or Missing Package Insert: The package i	Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include a	Class IIDrugs	Aug 6, 2021
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured fClass IIAug 6, 2021Labeling; Incorrect or Missing Package Insert: The package i	Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include a	Class IIDrugs	Aug 6, 2021