Class IIOngoing

Amphotericin B Liposome for Injection recall

FDA recall D-0493-2024 · initiated Apr 19, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Out of specification for assay

Details

Product: Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
Recalling company: Sun Pharm Industries
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Apr 19, 2024
FDA report date: May 15, 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-0493-2024 ↗

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