Denver Solutions, LLC DBA Leiters Health

22 FDA enforcement actions

22 Total Recalls

6 Class I

13 Class II

3 Class III

Firm Details

Product Types: drug
States: CO

All Recalls

Class II: Risk 03/31/2025 drug

Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II: Risk 03/31/2025 drug

Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II: Risk 03/31/2025 drug

Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II: Risk 03/31/2025 drug

Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II: Risk 03/31/2025 drug

Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II: Risk 02/20/2024 drug

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II: Risk 02/20/2024 drug

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II: Risk 02/20/2024 drug

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class I: Dangerous 12/28/2023 drug

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I: Dangerous 12/28/2023 drug

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I: Dangerous 12/28/2023 drug

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I: Dangerous 12/28/2023 drug

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I: Dangerous 12/28/2023 drug

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I: Dangerous 12/28/2023 drug

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class III: Low Risk 10/04/2023 drug

Labeling: Not Elsewhere Classified
Class III: Low Risk 10/04/2023 drug

Labeling: Not Elsewhere Classified
Class III: Low Risk 10/04/2023 drug

Labeling: Not Elsewhere Classified
Class II: Risk 02/21/2023 drug

CGMP DEVIATIONS
Class II: Risk 02/21/2023 drug

CGMP DEVIATIONS
Class II: Risk 02/21/2023 drug

CGMP DEVIATIONS
Class II: Risk 02/21/2023 drug

CGMP DEVIATIONS
Class II: Risk 11/29/2021 drug

Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL

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.