Recalls / Class III

Class IIID-0595-2024

Product

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).

Affected lot / code info

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

Why it was recalled

Cross contamination with other products

Recalling firm

Firm

Zydus Pharmaceuticals (USA) Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

73 Route 31 N, N/A, Pennington, New Jersey 08534-3601

Distribution

Quantity

12720 vials

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2024-07-02

FDA classified

2024-07-10

Posted by FDA

2024-07-17

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0595-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.