Class IIICompleted

Micafungin for injection recall

FDA recall D-0596-2024 · initiated Jul 2, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Cross contamination with other products

Details

Product: Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
Recalling company: Zydus Pharms USA
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA and Puerto Rico
Initiated: Jul 2, 2024
FDA report date: Jul 17, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0596-2024 ↗

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