FDAFDA · Food and drugs·Recall number D-1178-2023
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.
Published October 4, 2023 · Recall initiated: September 12, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ELIGARD
- Manufacturer
- Tolmar, Inc.
- Distributor
- Nationwide in the US.
- Lot
- Lot: 13635A1, Exp. 07/31/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.