# FDA recall D-821-2013

> **Gilead Sciences, Inc.** · Class II · drug recall initiated 2013-06-20.

## 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.

## Distribution

Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden.

## Key facts

- **Recall number:** D-821-2013
- **Recalling firm:** Gilead Sciences, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-20
- **Report date:** 2013-07-31
- **Termination date:** 2014-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foster City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-821-2013

## Citation

> AI Analytics. FDA recall D-821-2013. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-821-2013. Source: US FDA. Licensed CC0.

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