Denver Solutions, LLC DBA Leiters Health: 22 recalls on record

Recalls filed with 1 agency: FDA (22).

First recall on record: December 29, 2021. Most recent: April 30, 2025.

Risk classification: Class I: 6 · Class II: 13 · Class III: 3

Most recent recalls

DateAgencyProduct
April 30, 2025FDAKetamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Heal…D-0373-2025
April 30, 2025FDAdexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per…D-0371-2025
April 30, 2025FDAGlycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Heal…D-0370-2025
April 30, 2025FDARocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiter…D-0374-2025
April 30, 2025FDAPHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose …D-0372-2025
March 6, 2024FDAMoxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, En…D-0362-2024
March 6, 2024FDALidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Via…D-0363-2024
March 6, 2024FDAMoxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intra…D-0361-2024
February 7, 2024FDAPHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for …D-0279-2024
February 7, 2024FDAVANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV u…D-0281-2024
February 7, 2024FDAVANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV us…D-0282-2024
February 7, 2024FDAPHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for…D-0280-2024
February 7, 2024FDAFentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355…D-0277-2024
February 7, 2024FDAFentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342…D-0278-2024
November 1, 2023FDAVANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Co…D-0072-2024
November 1, 2023FDAVANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters C…D-0071-2024
November 1, 2023FDAOxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per m…D-0070-2024
March 15, 2023FDAPhenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compa…D-0443-2023
March 15, 2023FDAPhenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Comp…D-0442-2023
March 15, 2023FDAPhenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter…D-0444-2023
March 15, 2023FDAPhenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only,…D-0445-2023
December 29, 2021FDAMoxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/car…D-0288-2022

Questions about this company

How many recalls does Denver Solutions, LLC DBA Leiters Health have?
Recalert has 22 U.S. recalls on record for Denver Solutions, LLC DBA Leiters Health, published between December 29, 2021 and April 30, 2025.
What was the most recent Denver Solutions, LLC DBA Leiters Health recall?
FDA recall D-0373-2025, published April 30, 2025: 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
Which agencies have handled Denver Solutions, LLC DBA Leiters Health recalls?
Denver Solutions, LLC DBA Leiters Health appears as the recalling firm in recalls from: FDA (22).

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