Drug 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.
D-1178-2023
Product summary
- Firm
- Tolmar, Inc.
- Event
- Event 93044
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2990 cartons
- Official record key
drug-enforcement:D-1178-2023
Official wording
Reason: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Code information: Lot: 13635A1, Exp. 07/31/2024
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Potency or specification failure
Superpotent