Class III
Terminated
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.
This recall has been terminated (originally issued October 4, 2023).
- Company
- Tolmar, Inc.
- Recall Initiated
- September 12, 2023
- Posted
- October 4, 2023
- Recall Number
- D-1178-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2990 cartons
- Firm Location
- Fort Collins, CO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Distribution
Nationwide in the US.
Lot / Code Info
Lot: 13635A1, Exp. 07/31/2024
More recalls by Tolmar, Inc.
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