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.

FDA recall notice · announced October 4, 2023 · Tolmar

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US.
Lot/code information: Lot: 13635A1, Exp. 07/31/2024
Quantity: 2990 cartons
Status: Terminated
Products in this recall event:
- 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, (D-1178-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.