Reported Jul 31, 2013 · Terminated
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only,…
Astellas Pharma US Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Astellas Pharma US Inc · 1 Astellas Way · Northbrook, IL · 60062-6111
Is this the product you have?
- AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only
- Marketed byAstellas Pharma US, Inc., Northbrook, IL 60062
- Manufactured byGilead Sciences, Inc, San Dimas, CA 91773
- NDC0469-3051-30
- Lot codes and dates
- Lot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015. Lot Numbers and Expiry Dates (for Canada distribution). LOT 042269AA, EXP 07/2015, LOT 0422C1AA, EXP 11/2015.
- Amount recalled
- 133,550 Vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Astellas Pharma US Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.