Amphotericin B Injectable, Liposomal
FDA Recall NDC 62756-233
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Amphotericin B (NDC 62756-233). A significant event, classified as Class II, was initiated on Apr 19, 2024 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Out of specification for assay"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Out of specification for assay
Apr 19, 2024
May 15, 2024
11,016 vials
Recall Profile & Regulatory Data
Event ID
94442
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Affected Packages Involved in this Recall
62756-233-01Product
62756-233-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
