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.
Reported: October 4, 2023 Initiated: September 12, 2023 #D-1178-2023
Product Description
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.
Details
- Recalling Firm
- Tolmar, Inc.
- Units Affected
- 2990 cartons
- Distribution
- Nationwide in the US.
- Location
- Fort Collins, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tolmar, Inc.. Units affected: 2990 cartons.
Why was this product recalled? ▼
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 4, 2023. Severity: Low. Recall number: D-1178-2023.
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