FDA recall D-1178-2023

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.

Distribution

Nationwide in the US.

Key facts

Status

Terminated

Initiation date

2023-09-12

Report date

2023-10-04

Termination date

2024-10-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Collins, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1178-2023