Recalling firm
Tolmar, Inc.
Product type
Drug
Status
Terminated
Report date
2023-10-04
Distribution
Nationwide in the US.
Firm state
CO
Product quantity
2990 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
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.
Code / lot info
Lot: 13635A1, Exp. 07/31/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.