Tolmar, Inc.: Drug Recall

Recall #D-1178-2023 · 09/12/2023

Class III: Low Risk

Recall Details

Recall Number: D-1178-2023
Classification: Class III
Product Type: Drug
Recalling Firm: Tolmar, Inc.
Status: Terminated
Date Initiated: 09/12/2023
Location: Fort Collins, CO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2990 cartons

Reason for Recall

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

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.

Distribution Pattern

Nationwide in the US.

Other Recalls by Tolmar, Inc.

Class II: Risk 07/11/2022

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Class II: Risk 11/08/2021

Superpotent Drug

View all recalls by Tolmar, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.