Antifungal Injection Recalled

Sun Pharmaceutical Industries Inc. is recalling 11,016 vials of amphotericin B liposome for injection because assay results were out of specification, according to the May 15, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects amphotericin B liposome for injection, 50-mg vials (NDC 62756-233-01), from lots BAE0055A, BAE0056A, and BAE0068A (Exp. 3/26). The drug was manufactured by Sun Pharmaceutical Medicare Limited, Gujarat, India, and distributed by Sun Pharmaceutical Industries Inc. Cranbury, New Jersey, throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall on April 19, 2024. On May 8, 2024, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Amphotericin B liposome for injection is a prescription antifungal medication for intravenous infusion. Its indications include presumed fungal infection in febrile, neutropenic patients; cryptococcal meningitis in patients with HIV; patients with Aspergillus species, Candida species and/or Cryptococcus species infections; and visceral leishmaniasis treatment.