Partner Therapeutics Inc recalls LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Ther…

Recall date

June 23, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0655-2021

FDA classification

Class III

Brand / firm

Partner Therapeutics Inc

Sold / distributed

Product was distributed to one government account (ASPR)

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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