Home / Recalls / Denver Solutions, LLC DBA Leiters Health / D-0363-2024

D-0363-2024 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
March 6, 2024
Initiation Date
February 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40,890 vials

Product Description

Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.

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-0371-2025 Class II — dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg ( (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-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-0361-2024 Class II — Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injecti (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-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-0282-2024 Class I — VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, (December 28, 2023)
  • D-0281-2024 Class I — VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, (December 28, 2023)