Reported Apr 30, 2025 · Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters…
Denver Solutions, LLC dba Leiters Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Denver Solutions, LLC DBA Leiters Health · 13796 Compark Blvd · Englewood, CO · 80112-7145
Is this the product you have?
PHENYLephrine HCl in 0.9% Sodium Chloride0.5 mg per 5mL (100 mcg/mL)5 mL Single Dose SyringeRx OnlyLeiters Health13796 Compark BlvdEnglewoodCO 80112
- NDC71449-001-11
- Lot codes and dates
Lot #: 2431349AExp.: 6/16/2025
- Amount recalled
- 7,290 syringes
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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