Class III · Low risk Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141…
Reason Cross contamination with other products
Is Micafungin recalled?
6 FDA recalls mention Micafungin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Micafungin.
Class III · Low risk Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India…
Reason Cross contamination with other products
Class II · Moderate risk Terminated
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for…
Reason Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this…
Class II · Moderate risk Terminated
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia…
Reason Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this…
Class II · Moderate risk Terminated
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL…
Reason Labeling: Label Error on Declared Strength
Class II · Moderate risk Terminated
MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy…
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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