Antifungal Injection Recalled

Sun Pharmaceutical Industries Inc is recalling 12,960 vials of amphotericin B liposome for injection. According to the July 5, 2023, US Food and Drug Administration (FDA) Enforcement Report, the drug is subpotent.

The recall affects 50-mg vials of amphotericin B liposome for injection (NDC 62756-0233-01) from lots BAD0089A (Exp 1/25) and BAD0330A (Exp 7/25). The product was manufactured by Sun Pharmaceutical Medicare Limited, Gujarat, India, and distributed throughout the United States by Sun Pharmaceutical Industries Inc, Cranbury, New Jersey.

The recall was initiated May 30, 2023. On June 29, 2023, 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 drug indicated for the treatment of certain fungal infections including cryptococcal meningitis and visceral leishmaniasis. It is also indicated for fungal infections in patients who cannot receive conventional amphotericin B therapy.