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
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross contamination with other products
What was recalled
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 70710-1725-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0595-2024
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Micafungin recalls
See all
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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