LEUKINE — Class III drug recall D-0655-2021
Terminated recall by Partner Therapeutics Inc, reported 2021-07-21. FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 2
| Recall number | D-0655-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Partner Therapeutics Inc, Lynnwood, WA, United States |
| Recall initiated | 2021-06-23 |
| Classified | 2021-07-13 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2023-02-07 |
| Quantity | 32,260 vials |
| Reason classes | specification failure |
| NDC | 71837-5843, 71837-5843-01, 71837-5843-05 |
| Lot numbers | E8023E |
| Expiration dates | 2022-11-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0655-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.