NDC 71837-5843
Leukine 250 ug per 1 mL injection, powder, lyophilized, for solution
On the label: Partner Therapeutics, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Partner Therapeutics, Inc. | Lynnwood, WA, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJul 22, 2022 · 6 inspections, 1 with FDA action |
Recalls
- Jun 23, 2021 · Class III · Partner Therapeutics Inc
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Lots: Lot #: E8023E, exp. date 11/30/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sargramostim: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous; subcutaneous
- Strength
- 250 ug per 1 mL
- Approval
- BLA BLA103362
- On the market since
- Sep 1, 2023
- Package NDCs
71837-5843-171837-5843-5- Official label
- DailyMed (National Library of Medicine), updated Dec 6, 2024
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