Recalls / Class II
Class IID-820-2013
Product
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.
- Brand name
- Ambisome
- Generic name
- Amphotericin B
- Active ingredient
- Amphotericin B
- Route
- Intravenous
- NDC
- 0469-3051
- FDA application
- NDA050740
- Affected 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.
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.
Recalling firm
- Firm
- Astellas Pharma US Inc
- Manufacturer
- Astellas Pharma US, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Astellas Way, N/A, Northbrook, Illinois 60062-6111
Distribution
- Quantity
- 133,550 Vials
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2013-06-19
- FDA classified
- 2013-07-25
- Posted by FDA
- 2013-07-31
- Terminated
- 2014-02-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-820-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.