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.

Recall Number: D-1178-2023

Firm: Tolmar, Inc.

Classification: Class III

Status: Terminated

Report Date: 20231004

Initiation Date: 20230912

Termination Date: 20241003

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