Recall: D-1178-2023

Class III - Minor Violations

Class IIIClassification

2023-09-12Initiated

TerminatedStatus

Tolmar, Inc.Firm

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

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

Distribution

Nationwide in the US.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.