Reported Jul 31, 2013 · Terminated
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only,…
Gilead Sciences, 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: Gilead Sciences, Inc. · 333 Lakeside Drive · Foster City, CA · 94404-1147
Is this the product you have?
- AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only
- Marketed byAstellas Pharma US, Inc., Northbrook, IL 60062
- Manufactured byGilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30
- Lot codes and dates
Lot #: 042262AD042262AD1042263AD042263AD1042264AD042265AD042265AD1042265AD2Exp 06/201542269AK042270AD042270AD1042270AD3042270AD4042273ADExp 07/2015 and 07/2016 (Germany only)042285ADExp 08/2015 and 8/2016 (UK only)042293AA042293AE042293AK042298ADExp 09/20150422A6ADExp 10/15 (for FinlandGreeceTurkey) and Exp10/2016 (for SwedenUKLebanon)0422B0ADExp 10/2015 (for TurkeyNetherlandFrance)and Exp 10/2016 (for Poland)0422B0AD1Exp 10/20150422C1AA042304ADExp 01/2016 (Spain)and Exp 01/2017 (for GermanySwitzerland)042304AD1042311ADExp 01/2016and Exp 01/2017 (FranceUK)
- Amount recalled
- 478,352 vials
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.
This product could cause temporary or reversible health problems — stop using it.
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