Drug recall D-1178-2023
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 for recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Lots and codes
Lot: 13635A1, Exp. 07/31/2024
Recall details
- Recalling firm
- Tolmar, Inc., Fort Collins, CO
- Quantity
- 2990 cartons
- Distribution
- Nationwide in the US.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 12, 2023
- Terminated
- October 3, 2024
Related products
- Eligard – drug information
- NDC 62935-303 Eligard · · TOLMAR Inc.
- NDC 62935-753 Eligard · · TOLMAR Inc.
- NDC 62935-223 Eligard · · TOLMAR Inc.
- NDC 62935-453 Eligard · · TOLMAR Inc.