LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx onl...
FDA Recall #D-0655-2021 — Class III — June 23, 2021
Product Description
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.
Recalling Firm
Partner Therapeutics Inc — Lynnwood, WA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
32,260 vials
Distribution
Product was distributed to one government account (ASPR)
Code Information
Lot #: E8023E, exp. date 11/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated