Recall Enforment Report D-821-2013

Drug Recall Enforcement Report Class II voluntary initiated by Gilead Sciences, Inc., originally initiated on 06-20-2013 for the product 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. The product was recalled due to 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.. The product was distributed in 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. and the recall is currently terminated.

Field Name	Field Value
Event ID	65555 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-821-2013 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
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. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	478,352 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2013
Recall Initiation Date	06-20-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-05-2014 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Gilead Sciences, Inc.
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). Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0469-3051-30
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products