FDA recall D-0655-2021

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2021