Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted befo
Summary
The FDA issued a Class III for Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Ster by Tolmar, Inc.. Reason: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product..
Details
Source
Drug Recall
External ID
D-1178-2023
Action Date
2023-10-04
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot: 13635A1, Exp. 07/31/2024
Quantity Affected: 2990 cartons
Reason for Recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-12
Company
Fort Collins, CO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Tolmar, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tolmar, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tolmar, Inc. have FDA actions?
Tolmar, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1178-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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