Astellas Recalls Certain Lots of AmBisome

Astellas is voluntarily recalling certain lots of AmBisome (amphotericin B) liposome for injection due to a risk of bacterial contamination of the product. 

AmBisome is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of Cryptococcal Meningitis in HIV infected patients; treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotercin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotercin B deoxycholate; and for the treatment of visceral leishmaniasis.

The lots affected by this recall include the following:

Lot Number

Expiration Date

Lot Number

Expiration Date

042267AA

07/2015

042287AA

08/2015

042289AA

08/2015

042291AA

08/2015


These lots were distributed from November 2012 through February 2013. Astellas has not received any complaints or adverse reaction reports that it believes may be related to this issue thus far.

If a patient is currently receiving treatment with a product from an affected lot of AmBisome, discontinue treatment with the affected lot and use an alternative lot.  The patient should be monitored closely for any potential symptoms they may experience and treated as per standard medical practice.

Adverse reactions or quality problems should be reported to Astellas by calling (800) 727-7003 and FDA at (800) FDA-1088 or FDA.gov/Medwatch.