# FDA recall D-0655-2021

> **Partner Therapeutics Inc** · Class III · drug recall initiated 2021-06-23.

## Product

LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5

## Reason for recall

FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

## Distribution

Product was distributed to one government account (ASPR)

## Key facts

- **Recall number:** D-0655-2021
- **Recalling firm:** Partner Therapeutics Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-23
- **Report date:** 2021-07-21
- **Termination date:** 2023-02-07

- **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-0655-2021

## Citation

> AI Analytics. FDA recall D-0655-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0655-2021. Source: US FDA. Licensed CC0.

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