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.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-820-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 19, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 133,550 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Astellas Pharma US Inc
Original FDA data
Every field from FDA enforcement report D-820-2013, exactly as published.
Show all FDA fields
- City
- Northbrook
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65496
- Address
- 1 Astellas Way
- 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.
- Postal code
- 60062-6111
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-820-2013
- Classification
- Class II
- Recalling firm
- Astellas Pharma US Inc
- Product quantity
- 133,550 Vials
- Termination date
- Feb 4, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- Jun 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2013