# FDA recall D-820-2013

> **Astellas Pharma US Inc** · Class II · drug recall initiated 2013-06-19.

## 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.

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** D-820-2013
- **Recalling firm:** Astellas Pharma US Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-19
- **Report date:** 2013-07-31
- **Termination date:** 2014-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northbrook, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-820-2013

## Citation

> AI Analytics. FDA recall D-820-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-820-2013. Source: US FDA. Licensed CC0.

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