Leukine Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 71837-5843
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Leukine (NDC 71837-5843). A significant event, classified as Class III, was initiated on Jun 23, 2021 by Partner Therapeutics, Inc.. The reported reason for this action was: "FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Jun 23, 2021
Jul 21, 2021
32,260 vials
Recall Profile & Regulatory Data
Event ID
88164
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Partner Therapeutics Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to one government account (ASPR)
Termination Date
Feb 07, 2023
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
Batch or Lot Expiration Information
Lot# : E8023E, exp. date 11/30/2022
Affected Packages Involved in this Recall
71837-5843-1Product
71837-5843-5Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
