FDA recall D-0891-2023

Product

Amphotericin B Liposome for Injection, 50mg/vial, 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 62756-0233-01

Reason for recall

Subpotent drug

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2023-05-30

Report date

2023-07-05

Termination date

2023-12-18

Voluntary/Mandated

N/A

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2023