Medications & Supplements/Prescription Drugs

Zydus and Northstar Micafungin for Injection Recalled for Cross Contamination

Agency Publication Date: July 10, 2024

Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 12,720 vials of Micafungin (micafungin) for injection, USP, 100 mg/vial. This medication is used to treat various fungal infections. The recall was initiated because the product may have been cross-contaminated with other products during the manufacturing process. Affected products were sold under both the Zydus Pharmaceuticals and Northstar Rx LLC brand names.

Risk

Cross-contamination with other drug products can lead to unintended exposure to different medications, which may cause adverse reactions or reduce the effectiveness of the treatment.

What You Should Do

This recall affects Micafungin for injection, USP, 100 mg/vial, Single-Dose Vials, distributed under the Zydus Pharmaceuticals (USA) Inc. and Northstar Rx LLC brands.
For Zydus branded products, look for lot L300220 with an expiration date of 05/31/2025. This product uses NDC 70710-1725-01 for the vial and NDC 70710-1725-06 for the outer box.
For Northstar Rx LLC branded products, look for lot L300217 with an expiration date of 04/31/2025. This product uses NDC 16714-301-01 for the vial and NDC 16714-301-10 for the outer box.
Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Micafungin for injection, USP, 100 mg/vial

Variants: 100 mg/vial, Single-Dose Vial, Rx Only

Lot Numbers:

L300220 (Exp. 05/31/2025)

NDC:

70710-1725-01

70710-1725-06

Distributed by Zydus Pharmaceuticals (USA) Inc.

Product: Micafungin for injection, USP, 100 mg/vial

Variants: 100 mg/vial, Single-Dose Vial, Rx Only

Lot Numbers:

L300217 (Exp. 04/31/2025)

NDC:

16714-301-01

16714-301-10

Manufactured for Northstar Rx LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94922

Status: Resolved

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: Hospitals; Wholesalers; Pharmacies

Manufactured In: India

Units Affected: 2 products (12720 vials; n/a)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Micafungin for injection, USP, 100 mg/vial, Single-Dose Vials, distributed under the Zydus Pharmaceuticals (USA) Inc. and Northstar Rx LLC brands.

For Zydus branded products, look for lot L300220 with an expiration date of 05/31/2025. This product uses NDC 70710-1725-01 for the vial and NDC 70710-1725-06 for the outer box.

For Northstar Rx LLC branded products, look for lot L300217 with an expiration date of 04/31/2025. This product uses NDC 16714-301-01 for the vial and NDC 16714-301-10 for the outer box.

Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: Micafungin for injection, USP, 100 mg/vial

Variants: 100 mg/vial, Single-Dose Vial, Rx Only

Lot Numbers:

L300220 (Exp. 05/31/2025)

NDC:

70710-1725-01

70710-1725-06

Distributed by Zydus Pharmaceuticals (USA) Inc.

Product: Micafungin for injection, USP, 100 mg/vial

Variants: 100 mg/vial, Single-Dose Vial, Rx Only

Lot Numbers:

L300217 (Exp. 04/31/2025)

NDC:

16714-301-01

16714-301-10

Manufactured for Northstar Rx LLC.