Tolmar, Inc. recalls Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted bef…

Recall date

September 12, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1178-2023

FDA classification

Class III

Brand / firm

Tolmar, Inc.

Sold / distributed

Nationwide in the US.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.