Recall: D-0493-2024

Class II - Potentially Harmful

Class IIClassification

2024-04-19Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Reason

Out of specification for assay

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.