Drug recall
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be…
FDA recall event 93044 · Class III · Tolmar, Inc.
Key facts
| Event ID | 93044 |
|---|---|
| Recall numbers | D-1178-2023 |
| Recalling firm | Tolmar, Inc. |
| Product type | Drugs |
| 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. |
| Initiation date | Sep 12, 2023 |
| Report date | Oct 4, 2023 |
| Termination date | Oct 3, 2024 |
| City | Fort Collins |
| State | CO |
| Country | United States |
| FEI number | 3006218434 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: