Denver Solutions, LLC DBA Leiters Health recalls

6 official recalls and safety alerts involving Denver Solutions, LLC DBA Leiters Health since 2021-12, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Denver Solutions, LLC DBA Leiters Health or the relevant agency.

1. 2025-04-30
2. US
   Drugs & medicalClass II

   Denver Solutions, LLC DBA Leiters Health recalls Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd,…

   Lack of Assurance of Sterility: Leaking/damaged syringes.

   FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide in the U.S.AOfficial notice →
3. 2024-03-06
4. US
   Drugs & medicalClass II

   Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC…

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

   FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide in the USAOfficial notice →
5. 2024-02-07
6. US
   Drugs & medicalClass I

   Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark…

   Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

   FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United StatesOfficial notice →
7. 2023-11-01
8. US
   Drugs & medicalClass III

   Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796…

   Labeling: Not Elsewhere Classified

   FDA · DrugDenver Solutions, LLC DBA Leiters HealthUSA NationwideOfficial notice →
9. 2023-03-15
10. US
    Drugs & medicalClass II

    Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796…

    CGMP DEVIATIONS

    FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United States including VA or other Government facilitiesOfficial notice →
11. 2021-12-29
12. US
    Drugs & medicalClass II

    Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796…

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

    FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United StatesOfficial notice →