D-0493-2024 Class II Ongoing

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
May 15, 2024
Initiation Date
April 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,016 vials

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

Reason for Recall

Out of specification for assay

Distribution Pattern

Nationwide within the United States

Code Information

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