Eligard Kit
FDA Recall NDC 62935-753
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 Eligard (NDC 62935-753). A significant event, classified as Class III, was initiated on Sep 12, 2023 by Tolmar Inc.. The reported reason for this action was: "Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product."
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
September 2023 Class III Recall: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Recall Number
Class III Terminated
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Sep 12, 2023
Oct 04, 2023
2990 cartons
Recall Profile & Regulatory Data
Event ID
93044
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Tolmar, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US.
Termination Date
Oct 03, 2024
Product Description
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.
Batch or Lot Expiration Information
Lot# Lot: 13635A1, Exp. 07/31/2024
Affected Packages Involved in this Recall
62935-753-75Product
62935-754-74Product
62935-755-75Product
62935-223-05Product
62935-221-04Product
62935-224-05Product
62935-303-30Product
62935-305-29Product
62935-304-30Product
62935-453-45Product
62935-454-44Product
62935-455-45Product
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.
