Amphotericin B Liposome for Injection…

Date

May 15, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Sun Pharmaceutical Industries Inc

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

Reason

Out of specification for assay

Distribution pattern

Nationwide within the United States

Quantity

11,016 vials

Codes and lots

Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026

Recall started

April 19, 2024

Recall number

D-0493-2024

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0493-2024. The agency record governs; check it and the company before acting.