Home / Recalls / Tolmar, Inc. / D-1178-2023

D-1178-2023 Class III Terminated

Recalled by Tolmar, Inc. — Fort Collins, CO

Recall Details

Product Type
Drugs
Report Date
October 4, 2023
Initiation Date
September 12, 2023
Termination Date
October 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2990 cartons

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.

Distribution Pattern

Nationwide in the US.

Code Information

Lot: 13635A1, Exp. 07/31/2024

Other recalls by Tolmar, Inc.

  • D-1300-2022 Class II — Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tu (July 11, 2022)
  • D-0282-2022 Class II — Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR In (November 8, 2021)
  • D-66402-001 Class III — Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sand (September 23, 2013)