FDA-Drug2023-10-04Class III
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.
Tolmar, Inc.
Hazard
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Sold states
Nationwide in the US.
Affected count
2990 cartons
Manufactured in
701 Centre Ave, N/A, Fort Collins, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1178-2023Don't want to check this manually?
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