# FDA recall D-156-2013

> **Bayer HealthCare Pharmaceuticals Inc.** · Class III · drug recall initiated 2012-05-31.

## Product

Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2

## Reason for recall

Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-156-2013
- **Recalling firm:** Bayer HealthCare Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-31
- **Report date:** 2013-02-13
- **Termination date:** 2013-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lynnwood, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-156-2013

## Citation

> AI Analytics. FDA recall D-156-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-156-2013. Source: US FDA. Licensed CC0.

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