FDA Drug recall D-0655-2021
LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc
- FDA Drug
- Class III
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class III recall of LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc by Partner Therapeutics, citing FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0655-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-06-23 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Partner Therapeutics |
| Distribution | n/a |
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
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Identifiers
| ndc | 71837-5843-1 |
|---|---|
| ndc | 71837-5843-5 |
| code_info | Lot #: E8023E, exp. date 11/30/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.