Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Sun Pharmaceutical Industries INC

NDC code

62756-233-01

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0493-2024

Other Amphotericin recalls

See all

Class II · Moderate risk Terminated May 30, 2023

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512…

Reason Subpotent drug

Sun Pharmaceutical Industries INC NDC 62756-0233-01 D-0891-2023

Class II · Moderate risk Terminated Feb 3, 2023

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN…

Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Leadiant Biosciences, Inc. NDC 57665-101-41 D-0327-2023

Class II · Moderate risk Terminated Dec 6, 2021

CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1634-01 D-0432-2022

Class II · Moderate risk Terminated Dec 6, 2021

CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1633-05 D-0431-2022

Class II · Moderate risk Terminated Apr 2, 2019

Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1139-2019