Drug Enforcement D-1178-2023

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Status

Terminated

Classification

Class III

Report Date

October 4, 2023

Termination Date

October 3, 2024

Product Information

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.
Product quantity
2990 cartons
Reason for recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US.

Location & Firm

Recalling firm
Tolmar, Inc.
Address
701 Centre Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1178-2023
Event ID
93044
Recall initiation date
September 12, 2023
Center classification date
September 27, 2023
Code info
Lot: 13635A1, Exp. 07/31/2024
More code info
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