AmBisome — Class II drug recall D-821-2013
Terminated recall by Gilead Sciences, Inc., reported 2013-07-31. Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contami
| Recall number | D-821-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gilead Sciences, Inc., Foster City, CA, United States |
| Recall initiated | 2013-06-20 |
| Classified | 2013-07-25 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-03-05 |
| Countries outside the US | AE, AR, AT, BE, BR, CH, CL, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, MT, NL, NO, OM, PT, SA, SE, SG, SV, TH, TR |
| Quantity | 478,352 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 00469-3051-30 |
| Lot numbers | 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, 42269AK |
| Expiration dates | 2015-06, 2015-07, 2015-08, 2015-09, 2015-10, 2016-01, 2016-10, 2017-01 |
Product
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, 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 Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
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-821-2013. 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.