Tolmar, Inc.

3 FDA enforcement actions

3 Total Recalls

0 Class I

2 Class II

1 Class III

Firm Details

Product Types: drug
States: CO

All Recalls

Class III: Low Risk 09/12/2023 drug

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class II: Risk 07/11/2022 drug

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Class II: Risk 11/08/2021 drug

Superpotent Drug

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.