FDAFDA · Food and drugs·Recall number D-0372-2025
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,
Published April 30, 2025 · Recall initiated: March 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Leaking/damaged syringes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide in the U.S.A
- Lot
- Lot #: 2431349A, Exp.: 6/16/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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