The Recall Desk

FDA (Drugs) recall action 96607

Denver Solutions, LLC DBA Leiters Health recalled 5 products on 2025-04-30

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2025-04-30
Critical
0
Units
97,555

Why these products were recalled

Lack of Assurance of Sterility: Leaking/damaged syringes.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • SevereFDA (Drugs)··2025-04-30

    Ketamine HCl Syringes Recalled for Lack of Sterility Assurance

    Denver Solutions, LLC is recalling Ketamine HCl 50mg per 5mL single-dose syringes nationwide due to leaking or damaged syringes that may lack sterility assurance. Two affected lots are identified with expiration dates in July 2025.

    Product
    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2025-04-30

    Dexmedetomidine HCl Syringes Recalled for Potential Sterility Issue

    Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.

    Product
    dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2025-04-30

    PHENYLephrine HCl Injection Syringes Recalled for Lack of Sterility

    Denver Solutions, LLC DBA Leiters Health is recalling PHENYLephrine HCl 0.5 mg per 5mL single-dose syringes because some syringes may be leaking or damaged, which could compromise sterility assurance.

    Product
    PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-04-30

    Glycopyrrolate 1mg/5mL Syringes Recalled for Sterility Risk

    Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL single-dose syringes (Lot #2431015B, expiration 4/10/2025) distributed nationwide because some syringes were found to be leaking or damaged, which compromises sterility assurance.

    Product
    Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2025-04-30

    Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk

    Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.

    Product
    Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
    Category
    Distribution
    0 states