D-0493-2024Class II

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-05-15

Distribution

Nationwide within the United States

Firm state

Product quantity

11,016 vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Out of specification for assay

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification

2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc

See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.