Denver Solutions, LLC DBA Leiters Health: Drug Recall

Recall #D-0373-2025 · 03/31/2025

Class II: Risk

Recall Details

Recall Number: D-0373-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Denver Solutions, LLC DBA Leiters Health
Status: Ongoing
Date Initiated: 03/31/2025
Location: Englewood, CO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 49,830 syringes

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Product Description

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

Distribution Pattern

Nationwide in the U.S.A

Other Recalls by Denver Solutions, LLC DBA Leiters Health

Class II: Risk 03/31/2025

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

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

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

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

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

View all recalls by Denver Solutions, LLC DBA Leiters Health →

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.