AmBisome — Class II drug recall D-820-2013
Terminated recall by Astellas Pharma US Inc, reported 2013-07-31, distributed nationwide. Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of A
| Recall number | D-820-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Astellas Pharma US Inc, Northbrook, IL, United States |
| Recall initiated | 2013-06-19 |
| Classified | 2013-07-25 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 133,550 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 00469-3051-30 |
| Lot numbers | 042267AA, 042269AA, 042287AA, 042289AA, 042291AA, 0422C1AA |
| Expiration dates | 2015-07, 2015-07-20, 2015-08-20, 2015-11 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-820-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.