Reported Oct 4, 2023 · Terminated
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted…
Tolmar, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tolmar, Inc. · 701 Centre Ave · Fort Collins, CO · 80526-1843
Is this the product you have?
- Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75
- Manufactured byTolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526
- Lot codes and dates
- Lot
13635A1Exp. 07/31/2024
- Lot
- Amount recalled
- 2990 cartons
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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