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Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lif...

FDA Recall #D-0595-2024 — Class III — July 2, 2024

Recall #D-0595-2024 Date: July 2, 2024 Classification: Class III Status: Completed

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

Recalling Firm

Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

12720 vials

Distribution

Nationwide in the USA and Puerto Rico

Code Information

Lot #: L300220, Exp. 05/31/2025.

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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