CLASS II Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report

AmBisome (amphotericin B) liposome for Injection, 50 mg recalled

Gilead Sciences is recalling AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only. The recall was initiated on 20 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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).
Quantity recalled478,352 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-821-2013
FDA event ID
65555
Recalling firm
Gilead Sciences, Foster City, CA
Classification
Class II
Status
Terminated
Recall initiated
20 Jun 2013
FDA classified
25 Jul 2013
Reported
31 Jul 2013
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

20 Jun 2013Recall initiated by company
25 Jul 2013Classified by FDA+35 days
31 Jul 2013Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Questions about this recall

Is AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only recalled?

Yes. Gilead Sciences recalled AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only on 20 Jun 2013. The recall is Class II and its status is Terminated. Recall number D-821-2013.

Why was it recalled?

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.

Which lots are affected?

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).

Where was it sold?

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 should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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