Product Detail

Product Description AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.

Recall Number D-821-2013

Classification Class II

Code Info Lot #: 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, Exp 06/2015; 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, Exp 07/2015 and 07/2016 (Germany only); 042285AD, Exp 08/2015 and 8/2016 (UK only); 042293AA, 042293AE, 042293AK, 042298AD, Exp 09/2015; 0422A6AD, Exp 10/15 (for Finland, Greece, Turkey) and Exp10/2016 (for Sweden, UK, Lebanon), 0422B0AD, Exp 10/2015 (for Turkey, Netherland, France), and Exp 10/2016 (for Poland), 0422B0AD1, Exp 10/2015, 0422C1AA, 042304AD, Exp 01/2016 (Spain), and Exp 01/2017 (for Germany, Switzerland), 042304AD1, 042311AD, Exp 01/2016, and Exp 01/2017 (France, UK).

Product Distributed Qty 478,352 vials

Reason For Recall Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.

Event Detail

Event Id 65555

Product Type Drugs

Status Ongoing

Recalling Firm

Gilead Sciences, Inc.
City Foster City

State CA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-20

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Foreign distribution only to France, Italy, Switzerland,
Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden.