Denver Solutions, LLC DBA Leiters Health: Drug Recall

Recall #D-0442-2023 · 02/21/2023

Class II: Risk

Recall Details

Recall Number: D-0442-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Denver Solutions, LLC DBA Leiters Health
Status: Terminated
Date Initiated: 02/21/2023
Location: Englewood, CO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,445 units

Reason for Recall

CGMP DEVIATIONS

Product Description

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

Distribution Pattern

Nationwide within the United States including VA or other Government facilities

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 03/31/2025

Lack of Assurance of Sterility: Leaking/damaged syringes.

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.