PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 5, 2023 Initiated: May 30, 2023 #D-0891-2023

Product Description

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

Details

Units Affected
12960 vials
Distribution
USA nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 12960 vials.
Why was this product recalled?
Subpotent drug
Which agency issued this recall?
This recall was issued by the FDA Drug on July 5, 2023. Severity: Moderate. Recall number: D-0891-2023.