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SUN PHARMACEUTICAL INDUSTRIES INC recalls Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury

Recalled May 15, 2024 · FDA recall D-0493-2024 · SUN PHARMACEUTICAL INDUSTRIES

Hazard
Out of specification for assay · FDA Class II
Units
11,016 vials
Sold at
Nationwide within the United States

Description

Out of specification for assay

Product
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
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov