September 2023 FDA Recall Eligard by Tolmar, Inc.
D-1178-2023 - Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
This Class III drug recall was voluntarily initiated by Tolmar, Inc. on September 12, 2023 for the product Eligard. The FDA reported the reason for recall as superpotent drug - higher than expected levels of leuprolide acetate in the constituted product.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1178-2023
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
09-12-2023
10-04-2023
2990 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Tolmar, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US.
10-03-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: 13635A1, Exp. 07/31/2024
