Product: 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.
Reason for recall: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Recall initiated: 20230912
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated