D-820-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- June 19, 2013
- Termination Date
- February 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 133,550 Vials
Product Description
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
Reason for Recall
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.
Distribution Pattern
Nationwide and Canada
Code Information
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.