Home / Recalls / Denver Solutions, LLC DBA Leiters Health / D-0371-2025

D-0371-2025 Class II Ongoing

Recalled by Denver Solutions, LLC DBA Leiters Health — Englewood, CO

Recall Details

Product Type
Drugs
Report Date
April 30, 2025
Initiation Date
March 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,610 syringes

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Distribution Pattern

Nationwide in the U.S.A

Code Information

Lot #: 2431276A, Exp.: 4/20/2025

Other recalls by Denver Solutions, LLC DBA Leiters Health

  • D-0373-2025 Class II — Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Lei (March 31, 2025)
  • D-0372-2025 Class II — PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Sin (March 31, 2025)
  • D-0374-2025 Class II — Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx onl (March 31, 2025)
  • D-0370-2025 Class II — Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Lei (March 31, 2025)
  • D-0361-2024 Class II — Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injecti (February 20, 2024)
  • D-0363-2024 Class II — Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- (February 20, 2024)
  • D-0362-2024 Class II — Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark (February 20, 2024)
  • D-0277-2024 Class I — FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), I (December 28, 2023)
  • D-0278-2024 Class I — FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), I (December 28, 2023)
  • D-0280-2024 Class I — PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F (December 28, 2023)