Home / Recalls / Denver Solutions, LLC DBA Leiters Health / D-0372-2025

D-0372-2025 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: 7,290 syringes

Product Description

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,

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Distribution Pattern

Nationwide in the U.S.A

Code Information

Lot #: 2431349A, Exp.: 6/16/2025

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D-0361-2024 Class II — Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injecti (February 20, 2024)
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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)
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