US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 20, 2013 (13 years ago)

AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What was recalled

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.

Recalling firm
Gilead Sciences, Inc.
NDC code
0469-3051-30
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-821-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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