Astellas Pharma US Inc recalls AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Ma
Recalled July 31, 2013 · FDA recall D-820-2013 · Astellas Pharma US
Hazard
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills. · FDA Class II
Units
133,550 Vials
Sold at
Nationwide and Canada
Description
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Product
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
Manufacturer(s)
Astellas Pharma US Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →