June 2013 FDA Recall Ambisome by Gilead Sciences, Inc.
D-821-2013 - 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.

This Class II drug recall was voluntarily initiated by Gilead Sciences, Inc. on June 20, 2013 for the product Ambisome. The FDA reported the reason for recall as 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.

Recall Number: D-821-2013

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.
Initiated
06-20-2013
Reported
07-31-2013
Quantity
478,352 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65555
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gilead Sciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
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.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-05-2014
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

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).

Affected Packages Involved in this Recall

0469-3051-30 Ambisome