Drug recall D-0655-2021

Class III Terminated reported Jul 21, 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.

Lots and codes

Lot #: E8023E, exp. date 11/30/2022

Recall details

Recalling firm
Partner Therapeutics Inc, Lynnwood, WA
Quantity
32,260 vials
Distribution
Product was distributed to one government account (ASPR)
Type
Voluntary: Firm initiated
Recall initiated
June 23, 2021
Terminated
February 7, 2023

Related products