PlainRecalls
FDA Drug Low Class III Ongoing

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).

Reported: July 17, 2024 Initiated: July 2, 2024 #D-0595-2024

Product Description

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).

Reason for Recall

Cross contamination with other products

Details

Units Affected
12720 vials
Distribution
Nationwide in the USA and Puerto Rico
Location
Pennington, NJ

Frequently Asked Questions

What product 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).. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 12720 vials.
Why was this product recalled?
Cross contamination with other products
Which agency issued this recall?
This recall was issued by the FDA Drug on July 17, 2024. Severity: Low. Recall number: D-0595-2024.