Class II Terminated

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.

This recall has been terminated (originally issued July 31, 2013).

Company: Astellas Pharma Us Inc
Recall Initiated: June 19, 2013
Posted: July 31, 2013
Recall Number: D-820-2013
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 133,550 Vials
Firm Location: Northbrook, IL, United States
Official Source: View on FDA website ↗

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

Nationwide and Canada

Lot / Code Info

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.